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Combination Chemotherapy in Treating Patients With Lymphoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: April 18, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002835
  Purpose

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

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Biological: filgrastim
Biological: recombinant interferon alfa
Drug: carmustine
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: idarubicin
Drug: ifosfamide
Drug: leucovorin calcium
Drug: melphalan
Drug: methotrexate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Drug: vincristine sulfate
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A RANDOMIZED PROSPECTIVE STUDY OF EARLY INTENSIFICATION VS ALTERNATING TRIPLE THERAPY FOR PATIENTS WITH POOR PROGNOSIS LYMPHOMA

Resource links provided by NLM:


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

Estimated Enrollment: 136
Study Start Date: July 1995
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma

    • Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :

      • Ann Arbor stage III or IV disease
      • B symptoms (fever, sweats, and weight loss greater than 10%)
      • At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray
      • Beta-2 microglobulin at least 3.0
      • Lactic dehydrogenase at least 1.1 times the upper limit of normal
  • T- and B-cell lymphomas allowed if intermediate grade or immunoblastic
  • Divergent histologies, including bone marrow involvement, allowed
  • CNS involvement allowed 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 59

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)

Renal:

  • Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)

Cardiovascular:

  • LVEF greater than 50% by echocardiogram if over age 45
  • No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation

Pulmonary:

  • No history of chronic obstructive or restrictive lung disease
  • Pulmonary consultation required for smokers or patients with questionable lung function

Other:

  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)
  • No geographic, economic, emotional, or social condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No prior endocrine therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002835

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Richard E. Champlin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065044, MDA-DM-95121, NCI-V96-1010
Study First Received: November 1, 1999
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00002835     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I grade 3 follicular lymphoma
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 III grade 3 follicular 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 IV grade 3 follicular 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
contiguous stage II grade 3 follicular 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
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Angiogenesis Modulating Agents
Dermatologic Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Carmustine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Idarubicin
Neoplasms
Mitoxantrone
Interferon Alfa-2a
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009