Combination Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003541
First received: November 1, 1999
Last updated: June 20, 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. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have stage III or stage IV mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: CHOP regimen
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: prednisone
Drug: vincristine sulfate
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 24
Study Start Date: June 1998
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the response to a 8 week induction chemotherapy program consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with mantle cell lymphoma. II. Evaluate the efficacy of ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and filgrastim (G-CSF) for peripheral blood stem cell (PBSC) mobilization in this patient population. III. Evaluate the safety and efficacy of ICE followed by total body irradiation and high dose cyclophosphamide and etoposide in this patient population. IV. Assess the contamination of PBSCs by lymphoma cells following mobilization by chemotherapy and G-CSF in this patient population.

OUTLINE: Patients receive induction chemotherapy with cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, oral prednisone daily on days 2-6, and filgrastim (G-CSF) subcutaneously daily on days 6-10. Treatment is repeated every 14 days for up to 4 courses. Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2, etoposide IV daily on days 1-3, and G-CSF subcutaneously on days 5-12 for course 1, and on day 5 for course 2 and continuing through peripheral blood stem cell (PBSC) collection. Treatment is repeated every 14 days for 2 courses. Following PBSC collection, patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6, -5, and -4 and cyclophosphamide IV daily on days -3 and -2. PBSCs are infused on day 0. Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

PROJECTED ACCRUAL: Approximately 14-24 patients will be accrued for this study within two years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV mantle cell lymphoma (diffuse, nodular, mantle zone, or blastic variants)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic active or persistent hepatitis Bilirubin less than 2 mg/dL (unless history of Gilbert's disease) Renal: No history of chronic renal insufficiency Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: At least 6 months since myocardial infarction No unstable angina No cardiac arrhythmias other than chronic atrial fibrillation LVEF at least 50% Pulmonary: DLCO at least 50% Other: No medical illness that would preclude study treatment No uncontrolled infection No history of malignancy, other than curatively treated basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Not HIV positive

PRIOR CONCURRENT THERAPY: No prior therapy

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003541

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Carol S. Portlock, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003541     History of Changes
Other Study ID Numbers: 98-045, CDR0000066595, NCI-H98-0021
Study First Received: November 1, 1999
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Vincristine
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
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on October 01, 2014