Combination Chemotherapy in Treating Patients With Lymphoma
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|ClinicalTrials.gov Identifier: NCT00002835|
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : July 30, 2012
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 or disease||Intervention/treatment||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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma|
|Study Start Date :||July 1995|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
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: VePesidDrug: Ifosfamide
During Course 1, IV continuously; Course 2, IV continuously on days 1-3.
Other Name: IfexDrug: Melphalan
Other Name: AlkeranDrug: 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.
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: IdamycinDrug: 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
- Efficacy of Early Intensification vs. Alternating Triple Chemotherapy [ Time Frame: Monthly ]
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 ClinicalTrials.gov identifier (NCT number): NCT00002835
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Richard E. Champlin, MD||M.D. Anderson Cancer Center|