Combination Chemotherapy in Treating Patients With Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00002835
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012
  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 (BLM)
Biological: Filgrastim (G-CSF)
Biological: Recombinant Interferon Alfa
Drug: Carmustine
Drug: Cisplatin (CDDP)
Drug: Cyclophosphamide
Drug: Cytarabine (ARA-C)
Drug: Etoposide (VP-16)
Drug: Idarubicin
Drug: Ifosfamide
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Methotrexate
Drug: Methylprednisolone
Drug: mitoxantrone hydrochloride (DHAD)
Drug: Vincristine Sulfate
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Radiation Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy of Early Intensification vs. Alternating Triple Chemotherapy [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: July 1995
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

3 courses of early intensification:

First course: Ifosfamide (IFF) IV continuously and Etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest.

Second course: IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in first course.

Third course: Carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Filgrastim (G-CSF)
Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.
Other Names:
  • G-CSF
  • Neupogen
Drug: Carmustine
Arm 1, Course 3, IV over 1 hour on day -6.
Other Names:
  • BiCNU
  • BiCNUI
Drug: Cytarabine (ARA-C)
Arm 1, Course 3, every 12 hours on days -5 to -2.
Other Names:
  • ARA-C
  • Cytosar
  • DepotCyt
  • Cytosine arabinosine hydrochloride
Drug: Etoposide (VP-16)
Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.
Other Name: VePesid
Drug: Ifosfamide
During Course 1, IV continuously; Course 2, IV continuously on days 1-3.
Other Name: Ifex
Drug: Melphalan
Other Name: Alkeran
Drug: mitoxantrone hydrochloride (DHAD)
Arm 1, Course 2, IV on day 1.
Other Names:
  • mitoxantrone
  • Novantrone
Procedure: Peripheral Blood Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:
  • autologous peripheral blood stem cells
  • PBSC
Experimental: Arm II
IDSHAP during 4 week courses 2 and 5, MBIDCOS during courses 3 and 6, and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1, 4, and 7.
Biological: Bleomycin Sulfate (BLM)
Other Names:
  • Blenoxane
  • BLM
Biological: Recombinant Interferon Alfa Drug: Cisplatin (CDDP)
Other Names:
  • Platinol
  • Platinol-AQ
Drug: Cyclophosphamide
Other Names:
  • Cytoxan
  • Neosar
Drug: Idarubicin
Other Name: Idamycin
Drug: Leucovorin Calcium
Other Names:
  • Leucovorin
  • Citrovorum
  • Wellcovorin
Drug: Methotrexate Drug: Methylprednisolone
Other Names:
  • Depo-Medrol
  • Medrol
  • Solu-Medrol
Drug: Vincristine Sulfate Procedure: Peripheral Blood Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:
  • autologous peripheral blood stem cells
  • PBSC
Radiation: Radiation Therapy
Other Name: RT

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002835     History of Changes
Obsolete Identifiers: NCT00038740
Other Study ID Numbers: MDA DM95-121, P30CA016672, MDA-DM-95121, NCI-V96-1010, CDR0000065044
Study First Received: November 1, 1999
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
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:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bleomycin
Carmustine
Cyclophosphamide
Cytarabine
Etoposide
Ifosfamide
Interferon-alpha
Interferons
Levoleucovorin
Melphalan
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mitoxantrone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents

ClinicalTrials.gov processed this record on October 29, 2014