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Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002461
Recruitment Status : Completed
First Posted : March 26, 2004
Last Update Posted : August 17, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy to kill more cancer cells.

PURPOSE: This phase II trial is studying giving high-dose chemotherapy followed by bone marrow or peripheral stem cell transplantation to see how well it works in treating patients with refractory Hodgkin's disease or non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: sargramostim Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES: I. Determine the antitumor activity of intensive carmustine and etoposide with cisplatin or cyclophosphamide, followed by rescue with autologous bone marrow (ABM) treated in vitro with etoposide and/or peripheral blood stem cells mobilized with filgrastim (G-CSF) or sargramostim (GM-CSF) with or without radiotherapy in patients with refractory Hodgkin's disease or non-Hodgkin's lymphoma. II. Determine the time to recovery of peripheral blood counts in patients treated with this regimen. III. Correlate the rate of peripheral blood cell recovery in these patients with in vitro growth of ABM treated with etoposide.

OUTLINE: This is a multicenter study. Autologous bone marrow (ABM) is harvested and two-thirds of the ABM is treated in vitro with etoposide (VP-16). ABM may have been stored earlier in the course of the disease for patients who are at high risk of relapse or who were previously treated with agents causing bone marrow or stem cell damage (e.g., nitrosoureas, pelvic irradiation). Patients with prior bone marrow involvement and subsequent bone marrow remission must have received 1 or 2 additional courses of the same chemotherapy before undergoing harvest of ABM. Patients for whom PBSC rescue alone is planned also undergo ABM harvest in case back-up ABM rescue is needed. Patients then receive sargramostim (GM-CSF) or filgrastim (G-CSF) subcutaneously beginning 5 days before harvest of peripheral blood stem cells (PBSC) and continuing until completion of harvest. Patients without extensive prior radiotherapy undergo radiotherapy to areas of measurable active disease plus a 2 cm margin on days -21 to -17 and -14 to -8. Patients without a contraindication to cisplatin (e.g., hearing impairment, peripheral neuropathy) receive cisplatin IV over 3 hours on days -7 to -3 and carmustine IV over 2 hours and VP-16 IV over 4 hours on days -6 to -4. Patients with a contraindication to cisplatin receive cyclophosphamide IV every 12 hours, VP-16 IV over 1 hour every 12 hours, and carmustine IV over 1 hour on days -7 to -4. ABM and/or PBSC are reinfused on day 0. The first 6 ABM rescue patients receive untreated ABM and subsequent patients receive ABM treated in vitro with VP-16. Patients with bone marrow biopsy showing no evidence of regeneration (marrow cellularity less than 1%) at day 21 after PBSC rescue undergo back-up ABM rescue. Patients without engraftment (granulocyte count less than 500/mm3 and untransfused platelets no greater than 20,000/mm3) by day 28 after rescue with ABM treated in vitro with VP-16 undergo rescue with untreated ABM.

PROJECTED ACCRUAL: A total of 21-46 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Phase II Study of Intensive Carmustine and Etoposide With Cisplatin or Cyclophosphamide, Followed By Rescue With Autologous Bone Marrow Treated In Vitro With Etoposide and/or Peripheral Blood Stem Cells Mobilized With Filgrastim (G-CSF) or Sargramostim (GM-CSF) With or Without Radiotherapy in Patients With Resistant Hodgkin's Disease or Non-Hodgkin's Lymphoma
Actual Study Start Date : April 1988
Actual Primary Completion Date : July 1991
Actual Study Completion Date : July 1991

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Diagnosis of resistant Hodgkin's disease Eligible subtypes: Lymphocytic predominance Nodular sclerosing Mixed cellularity Lymphocyte depleted Not otherwise specified Must meet 1 of the following conditions: Disease progression after at least 1 course of prior therapy on each of 2 regimens comprising combination chemotherapy or radiotherapy Less than a partial remission (PR) after at least 2 courses on each of 2 regimens Failure to achieve a complete remission (CR) after 6 courses of 1 or 2 regimens Relapse less than 1 year off initial therapy OR Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma (NHL) Eligible subtypes: Diffuse poorly differentiated lymphocytic Diffuse mixed lymphocytic-histiocytic Nodular histiocytic Diffuse histiocytic Diffuse undifferentiated Lymphoblastic Must meet 1 of the following conditions: Disease progression after 1 course of prior therapy Failure to achieve a PR after 2 courses of prior therapy Failure to achieve a CR after 6 courses of prior therapy OR Diagnosis of low-grade NHL Eligible subtypes: Diffuse well-differentiated lymphocytic Nodular poorly differentiated lymphocytic Nodular mixed lymphocytic-histiocytic Failure on second-line therapy administered for progressive symptomatic disease or organ compromise Measurable disease by physical exam, external imaging or scanning studies, or tumor markers No severe symptomatic CNS disease of any etiology History of prior CNS tumor allowed if no signs or symptoms at study entry Active CNS lymphoma (meningeal lymphomatosis) rendered disease-free by conventional therapies allowed Epidural metastases or discrete parenchymal brain lesions allowed if tumors can be encompassed in standard treatment fields Bilateral marrow core biopsy free of tumor and showing at least 30% cellularity Prior marrow involvement allowed if marrow is histologically normal at time of storage No significant skin breakdown due to tumor or other 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 65 Performance status: Karnofsky 70-100% OR ECOG 0-1 Life expectancy: At least 8 weeks without transplantation Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL SGOT and SGPT less than 2 times normal No high risk for veno-occlusive disease of the liver Renal: No severe renal dysfunction unless due to tumor invasion Creatinine no more than 1.5 mg/dL Creatinine at least 60 mL/min Cardiovascular: No severe cardiovascular dysfunction unless due to tumor invasion No myocardial infarction within the past 6 months No symptoms of major heart disease Ejection fraction at least 50% by MUGA scan Essential hypertension controlled with medication allowed Pulmonary: No severe pulmonary dysfunction unless due to tumor invasion DLCO at least 50% normal No symptomatic obstructive or restrictive pulmonary disease Other: No insulin-dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No active infection HTLV-III negative (no AIDS-related complex)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) Prior exposure to etoposide, cisplatin, or carmustine allowed if cumulative dose of chloroethylnitrosourea (carmustine or lomustine) no greater than 400 mg/m2 Prior doxorubicin or daunorubicin dose of 450 mg/m2 or more allowed if LVEF at least 50% No concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids for hypercalcemia allowed Radiotherapy: See Disease Characteristics No prior whole-pelvic radiotherapy Other prior radiotherapy allowed Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina pectoris No concurrent antiarrhythmic drugs for major ventricular arrhythmias

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002461

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United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
National Cancer Institute (NCI)
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Study Chair: Rasim Ahmet Gucalp, MD Albert Einstein College of Medicine
Publications of Results:
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Responsible Party: Montefiore Medical Center Identifier: NCT00002461    
Other Study ID Numbers: 8802027
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2004    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Keywords provided by Montefiore Medical Center:
recurrent adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
adult mixed cellularity 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 lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent small lymphocytic lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors