Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00004907

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: busulfan Drug: cyclophosphamide Drug: etoposide Procedure: allogeneic bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase 1/Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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