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High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study


Phase 1/Phase 2
15 Years
60 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study


OBJECTIVES:

- Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA
identical related bone marrow or peripheral blood stem cell transplantation in patients
with relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or
non-Hodgkin's lymphoma.

- Determine the response rate and disease free survival in patients treated with this
regimen.

OUTLINE: HLA identical related donors undergo harvest of bone marrow or peripheral blood
stem cells (PBSC).

Patients are assigned to one of two treatment groups based on prior radiation to abdomen or
mediastinum:

- Group A (prior radiation no greater than 2,000 cGy): Patients with complete response
(CR) or partial response (PR) after completion of chemotherapy receive cyclophosphamide
IV over 1 hour on days -6 and -5, followed by total body irradiation twice daily on
days -4 to -1. Patients with minimal response after completion of chemotherapy receive
cyclophosphamide IV over 1 hour on days -8 and -7, followed by etoposide IV over 30
hours beginning on day -6, followed by total body irradiation twice daily on days -4 to
-1.

- Group B (prior radiation greater than 2,000 cGy): Patients with CR or PR after
completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4,
followed by cyclophosphamide IV over 1 hour on days -3 and -2. Patients with minimal
response after completion of chemotherapy receive oral busulfan every 6 hours on days
-9 to -6, followed by cyclophosphamide IV over 1 hour on days -5 and -4, followed by
etoposide IV over 30 hours beginning on day -3.

- Both groups: Bone marrow or PBSC are reinfused on day 0. Patients with bulky nodal
disease (greater than 5 cm) may undergo involved field radiotherapy two weeks before
transplantation.

Patients are followed every month for 1 year.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's
lymphoma, or non-Hodgkin's lymphoma of the following types:

- Diffuse small lymphocytic/marginal zone

- Grade I follicular small cleaved cell

- Grade II follicular mixed cell

- Diffuse small cleaved cell

- Grade III follicular large cell

- Diffuse mixed cell

- Diffuse large cell

- Immunoblastic large cell

- HLA identical related donor available

- Phenotypically HLA identical, MLC nonstimulatory donor eligible if no HLA
identical related donor is available

- Relapse following autologous bone marrow transplantation allowed if an HLA identical
related donor is available

- Eligible for total body irradiation

- No active uncontrolled CNS disease 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:

- Over 15 to physiologic age 60

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No congestive heart failure

- No myocardial infarction within the past 3 months

- No significant arrhythmia requiring medication

- Resting LVEF normal

Pulmonary:

- No significant nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary
disease) that would preclude therapy with cytotoxic drugs

- DLCO at least 50% of predicted* OR

- FEV1 and/or FVC at least 50% of predicted* NOTE: * Unless due to lymphoma, including
Hodgkin's lymphoma

Other:

- Not pregnant

- Negative pregnancy test

- No active serious medical condition that would preclude aggressive cytotoxic
chemotherapy

- HIV negative and no clinical evidence of AIDS

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Leo I. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 95H4T

NCT ID:

NCT00004907

Start Date:

October 1999

Completion Date:

August 2004

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • 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
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611