IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Combination Chemotherapy in Treating Patients With Lymphoma
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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:
MedlinePlus related topics:
Lymphoma
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Lymphoma, Large-cell
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
U.S. FDA Resources
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 ]
| 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:
Drug: Carmustine
Arm 1, Course 3, IV over 1 hour on day -6.
Other Names:
Drug: Cytarabine (ARA-C)
Arm 1, Course 3, every 12 hours on days -5 to -2.
Other Names:
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:
Procedure: Peripheral Blood Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:
|
|
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:
Biological: Recombinant Interferon Alfa
Drug: Cisplatin (CDDP)
Other Names:
Drug: Cyclophosphamide
Other Names:
Drug: Idarubicin
Other Name: Idamycin
Drug: Leucovorin Calcium
Other Names:
Drug: Methotrexate
Drug: Methylprednisolone
Other Names:
Drug: Vincristine Sulfate
Procedure: Peripheral Blood Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:
Radiation: Radiation Therapy
Other Name: RT
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 59 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
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
National Cancer Institute (NCI)
Investigators
| Study Chair: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| 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 ( US NIH Grant/Contract Award Number ) MDA-DM-95121 ( Other Identifier: UT MD Anderson Cancer Center ) NCI-V96-1010 CDR0000065044 ( Registry Identifier: NCI PDQ ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate Cytarabine Etoposide Idarubicin Mitoxantrone Cyclophosphamide Melphalan Etoposide phosphate |
Isophosphamide mustard Interferons Vincristine Cisplatin Bleomycin Ifosfamide Methylprednisolone Hemisuccinate Prednisolone Carmustine Interferon-alpha Lenograstim Levoleucovorin Methylprednisolone Prednisolone acetate Methylprednisolone acetate |
ClinicalTrials.gov processed this record on June 23, 2017