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


Phase 2
4 Years
N/A
Not Enrolling
Both
Breast Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Testicular Germ Cell Tumor, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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


OBJECTIVES:

- Determine the morbidity, mortality, and overall outcome in patients with hematologic
malignancies, breast cancer, or other chemosensitive solid tumors treated with
disease-specific dose-intensive conditioning regimens and autologous peripheral blood
or bone marrow transplantation.

OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk
includes acute leukemia in first relapse or second remission; lymphoma in responding first
relapse or second remission; or breast cancer at risk for recurrence. High risk includes all
others. Patients receive specific conditioning regimens according to diagnosis as outlined
below.

Conditioning

- Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide,
cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV
continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on
day -4. Patients undergo TBI on days -3 to -1.

- Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide,
carmustine, and etoposide (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.

- Regimen C (any risk patient with prior exposure to high-dose etoposide and
cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients
receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.

- Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive
melphalan IV over 30 minutes on day -2.

- Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients
receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and
cyclophosphamide IV over 2 hours on days -3 and -2.

- Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP
V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours,
and thiotepa IV over 24 hours on days -7 to -4.

- Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and
carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and
carboplatin IV continuously over 96 hours beginning on day -6.

- Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and
carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV
over 30 minutes on days -6 to -4.

Stem Cell Infusion

- In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment
continues in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen)
will be accrued for this study within 10 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed hematologic or solid tumor malignancy, including any of the
following:

- Acute myeloid leukemia

- First remission and not eligible for allogeneic transplantation; recurrent
disease after combination chemotherapy with at least 1 standard regimen; or
second remission

- Not eligible for protocol CLB-9620 or CLB-9621

- Acute lymphoblastic leukemia

- First complete remission without appropriate allogeneic donor

- Chronic myelogenous leukemia

- Chronic, accelerated, or blast phase

- Lymphoproliferative diseases*

- Chronic lymphocytic leukemia

- Multiple myeloma

- Waldenstrom's macroglobulinemia

- Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent,
symptomatic disease after first-line chemotherapy, or subsequently

- Amyloidosis

- Primary or previously treated disease

- NHL (intermediate- and high-grade)

- Resistant or recurrent disease after combination chemotherapy with at least
1 standard regimen

- First remission lymphoblastic or small, non-cleaved cell lymphoma at high
risk of relapse

- CNS disease OR bone marrow disease and lactic dehydrogenase greater
than 300 IU/L

- Hodgkin's lymphoma

- Resistant or recurrent disease after combination chemotherapy with at least
1 standard regimen

- Solid tumors

- High-risk and metastatic breast cancer

- Testicular cancer that has relapsed OR primary progressive disease that is
responding to salvage therapy

- Other solid tumors that have recurred after conventional therapy OR are at
high risk for relapse, and demonstrate chemosensitivity

- Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed
if purged)

- Allogeneic marrow transplantation not possible or not desirable for any of the
following reasons:

- Over 60 years of age

- No compatible donor identified

- Estimated risk of graft-versus-host disease complications greater than risk of
recurrence after autologous bone marrow transplantation

- Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more)
are not eligible for total body irradiation (TBI) regimens

- Hormone receptor status:

- Not specified 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:

Age

- 4 and over (patients 60 years of age and over are not eligible for TBI)

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 2 months

Hematopoietic

- WBC greater than 3,000/mm^3*

- Polymorphonuclear leukocyte count greater than 1,500/mm^3*

- Platelet count greater than 75,000/mm^3*

- Marrow cellularity greater than 20%*

- No marrow fibrosis* NOTE: *Before marrow storage

Hepatic

- Bilirubin less than 3 times normal

- Alkaline phosphatase less than 3 times normal

- AST less than 3 times normal

- Hepatitis status known

Renal

- Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis
or multiple myeloma)

Cardiovascular

- Ventricular ejection fraction at least 50% by radionuclide ventriculogram or
echocardiogram

- No myocardial infarction within the past 6 months

- No congestive heart failure

- No symptomatic angina

- No life-threatening arrhythmia or hypertension

Pulmonary

- DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or
alveolar ventilation)

Other

- Not pregnant

- HIV negative

- Cytomegalovirus status known

- No active bacterial, viral, or fungal infection

- No active peptic ulcer disease

- No uncontrolled diabetes mellitus

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

- No other serious medical or psychiatric illness that would preclude giving informed
consent or complying with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

- No prior cumulative nitrosourea dose greater than 600 mg/m^2

- No prior cumulative bleomycin dose greater than 150 units/m^2

- No prior cumulative doxorubicin dose greater than 450 mg/m^2

- No prior cumulative daunorubicin dose greater than 600 mg/m^2

- Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and
high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the
etoposide/cyclophosphamide/TBI conditioning regimen

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- More than 3 weeks since prior radiotherapy (before blood stem cell harvest)

- Prior cumulative doses of radiotherapy must not exceed the following:

- Spine/spinal cord: 4,000 cGy

- Mediastinum: 4,000 cGy

- Heart: 4,000 cGy

- Kidney (whole): 1,500 cGy

- Small bowel: 4,000 cGy

- Brain: 4,000 cGy

- Liver (whole): 2,000 cGy

- Lungs (whole): 1,500 cGy

- Bone: 5,000 cGy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity

Outcome Time Frame:

+day 100

Safety Issue:

No

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000301587

NCT ID:

NCT00060255

Start Date:

December 1991

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Testicular Germ Cell Tumor
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • stage IV breast cancer
  • male breast cancer
  • recurrent malignant testicular germ cell tumor
  • Waldenstrom macroglobulinemia
  • childhood acute lymphoblastic leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • recurrent childhood acute myeloid leukemia
  • childhood acute myeloid leukemia in remission
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • recurrent breast cancer
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Breast Neoplasms
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263