Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
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| ClinicalTrials.gov Identifier: NCT00002524 |
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Recruitment Status :
Completed
First Posted : October 5, 2004
Last Update Posted : July 30, 2012
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: Bleomycin Sulfate Biological: Filgrastim Drug: Cisplatin Drug: Cyclophosphamide Drug: Cytarabine Drug: Doxorubicin Hydrochloride (DOX) Drug: Etoposide Drug: Fluorouracil Drug: Ifosfamide Drug: Leucovorin calcium Drug: Methotrexate Drug: Methylprednisolone Drug: Pentamidine Drug: Prednisone Drug: Trimethoprim-Sulfamethoxazole Drug: Vincristine Sulfate Drug: Zidovudine (AZT) Radiation: Radiation Therapy | Phase 2 |
OBJECTIVES: I. Develop an effective chemotherapy regimen with mild immunosuppressive and myelosuppressive properties to treat patients with AIDS-related lymphoma (ARL) who have severe T4 lymphopenia. II. Estimate the CR rate, lymphoma-free survival, and overall survival of non-T4 lymphopenic patients and patients who present with nonbulky Ann Arbor stage I ARL treated with standard regimens of known effectiveness. III. Evaluate the effects on long-term outlook of concurrent antiretroviral therapy, prophylactic antibiosis with trimethoprim/sulfamethoxazole or aerosolized pentamidine, and prn use of granulocyte colony-stimulating factor for severe myelosuppression.
OUTLINE: Patients are assigned to Regimens A, B, and C according to histology and extent of disease and the degree of immunosuppression as follows: Regimen A: Patients with Ann Arbor stage I intermediate grade or immunoblastic lymphoma with measurable nonbulky disease (less than 7 cm), low LDH (less than 686), and no prior opportunistic infection irrespective of T4 count; also those with nonmeasurable stage I extranodal primaries (infiltration of less than 2/3 of an organ site, e.g., stomach, rectum, esophagus, sinus cavity) irrespective of T4 count. Regimen B: All patients (except primary brain lymphoma patients) not assigned to Regimen A who have T4 counts of at least 200 and no history of opportunistic infection; includes all stages of small noncleaved cell lymphoma and bulky stage I and stages II-IV intermediate grade and immunoblastic lymphoma. Regimen C: Patients not assigned to Regimen A or B, i.e., those with T4 counts less than 200 and/or a history of opportunistic infection and those with primary brain lymphoma. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 5-FU Fluorouracil, NSC-19893 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109723 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 MTX Methotrexate, NSC-740 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 ZDV Zidovudine, NSC-602670 Regimen A: 5-Drug Combination Chemotherapy followed by Radiotherapy. CHOP-BLEO: CTX; DOX; VCR; PRED; BLEO; followed by involved-field irradiation with megavoltage equipment. Regimen B: 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy. ASHAP: DOX; MePRDL; ARA-C; CDDP; alternating with IMVP-16: IFF/Mesna; MTX/CF; VP-16; followed, in selected patients with initially bulky localized disease, by involved-field irradiation with megavoltage equipment. Regimen C: 2-Drug Combination Chemotherapy with Drug Modulation followed, as indicated, by Radiotherapy. FLEP: 5-FU/CF/CDDP; followed, in selected patients with initially bulky localized disease, by involved-field irradiation with megavoltage equipment. Prior to starting chemotherapy, patients with primary brain lymphoma receive a course of cranial irradiation using accelerator beams with photon energies of 6-15 MV.
PROJECTED ACCRUAL: Up to 92 patients (10 for Regimen A, 28 for Regimen B, 54 for Regimen C) will be entered over 3 years. If there are no CRs among the first 6 patients on Regimens A and B or the first 19 patients on Regimen C, accrual to that regimen will cease. If more than 4 infectious deaths occur among the first 10 patients or if the rate of disease progression exceeds 20% on any regimen, further accrual to that regimen will cease.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 46 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pilot Study in AIDS-Related Lymphomas |
| Study Start Date : | June 1993 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Regimen A
Regimen A: 5-Drug Combination Chemotherapy followed by Radiotherapy.
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Biological: Bleomycin Sulfate
Other Names:
Drug: Cyclophosphamide Other Names:
Drug: Doxorubicin Hydrochloride (DOX) Other Names:
Drug: Pentamidine Other Name: Pentam-300 Drug: Prednisone Drug: Trimethoprim-Sulfamethoxazole Other Names:
Drug: Vincristine Sulfate Drug: Zidovudine (AZT) Other Name: Retrovir Radiation: Radiation Therapy Other Names:
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Experimental: Regimen B
Regimen B: 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy
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Biological: Filgrastim
Other Names:
Drug: Cytarabine Other Names:
Drug: Doxorubicin Hydrochloride (DOX) Other Names:
Drug: Etoposide Other Name: VePesid Drug: Ifosfamide Other Name: Ifex Drug: Methotrexate Drug: Methylprednisolone Other Names:
Drug: Pentamidine Other Name: Pentam-300 Drug: Trimethoprim-Sulfamethoxazole Other Names:
Drug: Zidovudine (AZT) Other Name: Retrovir Radiation: Radiation Therapy Other Names:
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Experimental: Regimen C
Regimen C: 2-Drug Combination Chemotherapy with Drug Modulation followed, as indicated, by Radiotherapy.
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Biological: Filgrastim
Other Names:
Drug: Cisplatin Other Names:
Drug: Fluorouracil Other Names:
Drug: Leucovorin calcium Other Names:
Drug: Pentamidine Other Name: Pentam-300 Drug: Trimethoprim-Sulfamethoxazole Other Names:
Drug: Zidovudine (AZT) Other Name: Retrovir Radiation: Radiation Therapy Other Names:
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- Number of Patients with Clinical Response [ Time Frame: 3 Years ]Clinical Responses categorized by: Complete Response (CR), Partial Response (PR), Minor Response, Stable Disease or Progressive Disease
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Previously untreated, HIV-related intermediate- and high-grade lymphoma with no previous diagnosis of Kaposi's sarcoma Pathology reviewed at M.D. Anderson Cancer Center
PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: For patients with T4 less than 200 and those with primary brain lymphoma: Creatinine no greater than 2.0 mg/dL (unless entry approved by principal investigator) Other: Serious intercurrent illness must be discussed with the principal investigator Infectious disease consultation required for complex infections Medications for other conditions allowed provided no adverse interaction with protocol therapy occurs No previously diagnosed Kaposi's sarcoma or other malignancy
PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma No concurrent chemotherapy
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): NCT00002524
| United States, Florida | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Peter W. McLaughlin, MD | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002524 |
| Other Study ID Numbers: |
DM93-058 P30CA016672 ( U.S. NIH Grant/Contract ) MDA-DM-93058 ( Other Identifier: UT MD Anderson Cancer Center ) NCI-T93-0088D CDR0000078316 ( Registry Identifier: NCI PDQ ) |
| First Posted: | October 5, 2004 Key Record Dates |
| Last Update Posted: | July 30, 2012 |
| Last Verified: | July 2012 |
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AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma |
AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma |
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Lymphoma Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leucovorin Cytarabine Zidovudine Trimethoprim Sulfamethoxazole |
Trimethoprim, Sulfamethoxazole Drug Combination Pentamidine Prednisone Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Cyclophosphamide Ifosfamide Doxorubicin Liposomal doxorubicin Fluorouracil Methotrexate Etoposide |