Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease (CBV)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00005613
First received: May 2, 2000
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: etoposide
Drug: BCNU
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • relapse rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation


Enrollment: 147
Study Start Date: March 1996
Study Completion Date: June 2010
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Transplant
autologous hematopoietic progenitor cell transplant
Drug: cyclophosphamide
Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
Other Name: cyclophosphamide
Drug: etoposide
Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
Other Name: vp-16
Drug: BCNU
BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4
Other Name: Carmustine
Experimental: Allogeneic Transplant
allogeneic hematopoietic progenitor cell trasnplant
Drug: cyclophosphamide
Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
Other Name: cyclophosphamide
Drug: etoposide
Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
Other Name: vp-16
Drug: BCNU
BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4
Other Name: Carmustine

Detailed Description:

OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that has relapsed or failed to achieve complete remission after first line induction chemotherapy Intermediate or high grade (including mantle cell, but excluding lymphoblastic disease) No more than 1 prior salvage chemotherapy regimen, e.g.: Dexamethasone, high dose cytarabine, and cisplatin (DHAP) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP) Low grade No more than 2 prior salvage chemotherapy regimens, e.g.: Fludarabine, mitoxantrone, and dexamethasone (FND) ESHAP DHAP OR Histologically proven stage III or IV Hodgkin's disease that has relapsed or failed to achieve remission after combination induction chemotherapy Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, liver/marrow involvement) No more than 2 prior salvage chemotherapy regimens Allogeneic stem cell transplantation group: Availability of 6 antigen (A, B, and DR loci) HLA matched sibling donor No active CNS disease 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: 15 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 times normal PT and PTT normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 45% by MUGA scan or echocardiogram No myocardial infarction within the past 6 months No arrhythmias unless medically controlled Pulmonary: FEV1 at least 50% predicted DLCO at least 50% predicted Other: No diabetes mellitus or thyroid disease unless medically controlled No active serious infection HIV negative Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005613

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Steven C. Goldstein, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00005613     History of Changes
Other Study ID Numbers: 11306, MCC-11306, IRB-4250, NCI-G00-1746
Study First Received: May 2, 2000
Last Updated: June 3, 2013
Health Authority: United States: Federal Government

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult 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 adult Burkitt lymphoma
recurrent mantle cell lymphoma
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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Etoposide phosphate
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014