Know Cancer

or
forgot password

Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors


Phase 2
4 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Neuroblastoma, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors


OBJECTIVES:

Primary

- Compare the progression-free survival (PFS) of patients with Hodgkin lymphoma (HL) or
non-Hodgkin lymphoma (NHL) treated with different disease-specific high-dose
conditioning regimens followed by autologous stem cell transplantation.

- Compare the PFS of patients with high-risk vs standard-risk HL, NHL, or multiple
myeloma, in terms of disease progression or relapse after transplant.

- Determine if known prognostic factors (when available) can be used to group patients
with acute lymphocytic leukemia or acute myeloid leukemia into high risk and standard
risk groups.

Secondary

- Compare the toxicity of the different disease-specific high-dose conditioning regimens
in these patients.

- Compare the overall survival of patients treated with these regimens.

OUTLINE: Patients are retrospectively stratified according to risk for recurrence (low
[standard]-risk vs high-risk). Patients are assigned to a conditioning regimen based on
disease, age, and co-morbidities.

- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL): Patients receive 1
of the following conditioning regimens followed by autologous stem cell transplant
(ASCT):

- CT6: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and
undergo total-body irradiation twice daily on days -3 to -1. Patients undergo ASCT
on day 0.

- BuC2iv: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4
for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2.
Patients undergo ASCT on day 0.

- Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL): Patients receive 1 of the
following conditioning regimens followed by ASCT:

- CBV: Patients receive etoposide IV continuously over 34 hours beginning on day -8,
cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours
on day -3. Patients undergo ASCT on day 0.

- BuC2iv: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4
for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2.
Patients undergo ASCT on day 0.

- Multiple myeloma (MM) or amyloidosis: Patients receive 1 of the following conditioning
regimens followed by ASCT:

- M200: Patients receive 200 mg/m² of melphalan IV over 30 minutes on day -2.
Patients undergo ASCT on day 0.

- M120: Patients receive 120 mg/m² of melphalan IV over 30 minutes on day -2.
Patients undergo ASCT on day 0.

- Testicular cancer: Patients receive the following conditioning regimen followed by
tandem ASCT:

- VCp: Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30
minutes on days -6 to -4. Patients undergo ASCT on day 0. Approximately 4-8 weeks
after the first transplant, patients receive etoposide IV over 2-3 hours and
carboplatin IV over 30 minutes on days -6 to -4. Patients undergo a second ASCT on
day 0.

- Neuroblastoma or small round blue cell tumor: Patients receive the following
conditioning regimen followed by tandem ASCT:

- TtC1500/ECpM: Patients receive thiotepa IV over 2 hours on days -7 to -5 and
cyclophosphamide IV over 1-2 hours on days -5 to -2. Patients undergo ASCT on day
0. Approximately 4-8 weeks after the first transplant, patients receive etoposide
IV continuously and carboplatin IV continuously on days -7 to -4 and melphalan IV
over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.

- Other solid tumors: Patients receive the following conditioning regimen followed by
ASCT:

- CTtCp: Patients receive cyclophosphamide IV continuously, carboplatin IV
continuously, and thiotepa IV continuously on days -7 to -4. Patients undergo ASCT
on day 0.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Hodgkin lymphoma, meeting the following criteria:

- Relapsed or refractory disease after ≥ 1 prior standard chemotherapy
regimen

- Must have received 2 prior courses of salvage chemotherapy followed by
disease-specific restaging prior to mobilization and collection of stem
cells

- Non-Hodgkin lymphoma, meeting the following criteria:

- Low-, intermediate-, or high-grade disease, meeting 1 of the following
criteria:

- Relapsed or refractory disease after ≥ 1 prior standard chemotherapy
regimen

- Small non-cleaved cell or lymphoblastic lymphoma in first complete
remission (CR) at high risk for relapse by IPI score

- Must have received 2 prior courses of salvage chemotherapy followed by
disease-specific restaging prior to mobilization and collection of stem
cells

- Acute myeloid leukemia, meeting the following criteria:

- Low- or high-risk disease in first or second CR or greater

- Must have received 2 prior courses of chemotherapy (induction chemotherapy
and mobilization chemotherapy) followed by disease-specific restaging prior
to mobilization and collection of stem cells

- Risk of allogeneic stem cell transplantation outweighs the benefits

- Acute lymphoblastic leukemia, meeting the following criteria:

- Low- or high-risk disease in first or second CR or greater

- Must have received 2 prior courses of chemotherapy (induction chemotherapy
and mobilization chemotherapy) followed by disease-specific restaging prior
to mobilization and collection of stem cells

- Risk of allogeneic stem cell transplantation outweighs the benefits

- Multiple myeloma, meeting the following criteria:

- Low- or high-risk disease in first or greater response (stable disease or
better) OR responding disease and now in first progression

- Must have received 2 prior courses of chemotherapy (≥ 1 of the courses must
have been standard induction therapy) followed by disease-specific
restaging prior to mobilization and collection of stem cells

- Other malignant lymphoproliferative disease, including chronic lymphocytic
leukemia or Waldenstrom macroglobulinemia, meeting the following criterion:

- Relapsed or refractory disease after first-line chemotherapy

- Amyloidosis, meeting the following criteria:

- Primary or previously treated disease

- Prior induction chemotherapy is not required

- Patients with malignancies who would be treated with an autologous stem cell
transplant but have a syngeneic donor. A syngeneic donor would be considered to
have the same risk as an autologous stem cell transplant patient.

- Solid tumors, including any of the following:

- Testicular cancer, meeting the following criteria:

- Relapsed disease or primary progressive disease that responded to
salvage therapy

- Must have received 2 prior courses of salvage chemotherapy
followed by disease-specific restaging prior to mobilization and
collection of stem cells

- Neuroblastoma, meeting the following criteria:

= 30 years of age or under

- Relapsed disease OR newly diagnosed advanced disease

- Must have received 2 prior courses of chemotherapy (induction chemotherapy and
mobilization chemotherapy) followed by disease-specific restaging prior to
mobilization and collection of stem cells

- Small round blue cell tumor, meeting the following criteria:

= 30 years of age or under

- Relapsed disease OR newly diagnosed advanced disease

- Must have received either prior standard chemotherapy or surgical intervention

- Other solid tumor, meeting the following criteria:

- Recurrent disease following conventional therapy OR at high risk for relapse

- Must have received 2 prior courses of chemotherapy followed by disease-specific
restaging prior to mobilization and collection of stem cells

- Demonstrates chemosensitivity

- Allogeneic stem cell transplantation (SCT) is not possible, or is not desirable
(e.g., over 65 years of age; no compatible donor available; and estimated risk
of graft-versus-host disease complications are greater than risk of recurrence
after autologous SCT)

- Adequate bone marrow or peripheral blood stem cell dose obtained

- Total CD34+ peripheral blood stem cell dose ≥ 2 x 10^6/kg, or if unable to
collect this dose, total nucleated cell bone marrow dose ≥ 1 x 10^8/kg

- Bone marrow may be used in conjunction with blood progenitor cells NOTE: A
new classification scheme for adult non-Hodgkin's lymphoma has been adopted
by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace
the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 70-100% or PS 0-2

- Patients with amyloidosis or multiple myeloma with decreased Karnofsky PS due to
disease are eligible

- Life expectancy > 2 months

- ANC > 1,500/mm³

- Platelet count > 75,000/mm³

- Bilirubin < 3 times upper limit of normal (ULN)

- Alkaline phosphatase < 3 times ULN

- SGOT < 3 times ULN

- Creatinine clearance ≥ 50 mL/min (requirement waived in selected multiple myeloma and
amyloidosis patients due to renal compromise characteristic of the disease)

- Glomerular filtration rate by renal scan required for patients with
neuroblastoma

- HIV I and HIV II antibody negative

- DLCO or DLVA ≥ 50% of predicted (DLCO to be corrected for hemoglobin and/or alveolar
ventilation)

- Cardiac ventricular ejection fraction ≥ 50% by radionuclide ventriculogram or
echocardiogram

- No uncontrolled or severe cardiovascular disease, including any of the following:

- Myocardial infarction within the past 6 months

- Congestive heart failure

- Symptomatic angina

- Life-threatening arrhythmia

- Hypertension

- No active bacterial, viral, or fungal infection

- Patients with positive CMV IgM and/or positive hepatitis serologies
demonstrating infection, or any other active infection, will require an
Infectious Disease consult and subsequent clearance

- No active peptic ulcer disease

- No uncontrolled diabetes mellitus

- No other serious organ dysfunction unless it is caused by the underlying disease

- No serious medical or psychiatric illness

- No psychiatric condition that would prevent delivery of care (psychology clearance is
necessary)

- Not pregnant

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No radiotherapy within 3 weeks prior to stem cell harvest

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000565267

NCT ID:

NCT00536601

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Neuroblastoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • disseminated neuroblastoma
  • localized unresectable neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • primary systemic amyloidosis
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent childhood grade III lymphomatoid granulomatosis
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • Burkitt lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • refractory chronic lymphocytic leukemia
  • Waldenstrom macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • splenic marginal zone lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • stage I adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • cutaneous B-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Nervous System Neoplasms
  • Neuroblastoma
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, Non-Hodgkin
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263