Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	Fox Chase Cancer Center CCOP Research Base
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002521

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow doctors to give high doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell transplantation in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy Procedure: syngeneic bone marrow transplantation	Phase II

MedlinePlus related topics: Bone Marrow Transplantation Cancer Lymphoma

Drug Information available for: Cyclophosphamide Etoposide Cisplatin Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY NON-HODGKIN'S LYMPHOMA (INTERMEDIATE AND HIGH-GRADE HISTOLOGIES)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 1993

Detailed Description:

OBJECTIVES:

Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell rescue in patients with relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma.
Determine the overall response rate and survival of patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.
Determine the differences in the rates of engraftment, response, and survival of patients treated with bone marrow vs peripheral blood stem cell transplantation.
Determine the response rate and survival of patients treated with consolidative radiotherapy after recovery from transplantation.
Determine the toxic effects of consolidative radiotherapy after recovery from transplantation in these patients.

OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.

Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)

After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma
- Eligible subtypes:
  - Diffuse small cleaved cell
  - Diffuse mixed (small and large cell)
  - Diffuse large cell
  - Large cell immunoblastic
  - Lymphoblastic
  - Small noncleaved cell
High-grade histology patients should first be considered for Protocol TUHSC-1520
Must have chemosensitive disease, defined by 1 of the following conditions:
- Response to initial chemotherapy without obtaining complete response (CR)(refractory lymphoma)
- Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25% for more than 1 month after completion of 1-3 courses of salvage chemotherapy (chemosensitive relapse)
No chemoresistant disease, defined by the following conditions:
- Unresponsive or progressive disease during initial chemotherapy
- Relapse after chemotherapy-induced CR if tumor volume not reduced by at least 25% after completion of 1-3 courses salvage chemotherapy (chemoresistant relapse)
No CNS involvement by lymphoma
Syngeneic bone marrow transplantation offered to patients with consenting identical twin donor 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:

15 to 60 (physically fit patients up to age 70 may be considered)

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 2.0 mg/dL
AST and ALT not persistently greater than 2 times normal

Renal:

Creatinine less than 1.8 mg/dL

Cardiovascular:

Cardiac ejection fraction at least 45%

Pulmonary:

DLCO, FEV_1, and FVC at least 50% predicted
Resting pO_2 at least 70 mm Hg

Other:

HIV negative
No other concurrent disease that would limit life expectancy
No active infection
No severe neurologic or emotional disorders
Not pregnant
Fertile patients must use effective contraception
Adequate psychological support available

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002521

Locations

United States, Pennsylvania
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2442

Sponsors and Collaborators

Fox Chase Cancer Center CCOP Research Base

Investigators

Study Chair:

Kenneth F. Mangan, MD, FACP

Fox Chase Cancer Center CCOP Research Base

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000078282, TUHSC-2161, NCI-V93-0248
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002521
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma

stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt 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 lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult lymphoblastic lymphoma

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Cyclophosphamide
Lymphoblastic lymphoma
Etoposide phosphate
Recurrence
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell

Burkitt's lymphoma
Lymphatic Diseases
Cisplatin
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009