Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

NCT00002524 | Completed Phase 2

• 5 other identifiers: DM93-058P30CA016672MDA-DM-93058NCI-T93-0088DCDR0000078316
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Clinical Response

  Clinical Responses categorized by: Complete Response (CR), Partial Response (PR), Minor Response, Stable Disease or Progressive Disease

  3 Years

Study Arms (3)

Regimen A

EXPERIMENTAL

Regimen A: 5-Drug Combination Chemotherapy followed by Radiotherapy.

Biological: Bleomycin Sulfate; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride (DOX); Drug: Pentamidine; Drug: Prednisone; Drug: Trimethoprim-Sulfamethoxazole; Drug: Vincristine Sulfate; Drug: Zidovudine (AZT); Radiation: Radiation Therapy

Regimen B

EXPERIMENTAL

Regimen B: 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy

Biological: Filgrastim; Drug: Cytarabine; Drug: Doxorubicin Hydrochloride (DOX); Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Pentamidine; Drug: Trimethoprim-Sulfamethoxazole; Drug: Zidovudine (AZT); Radiation: Radiation Therapy

Regimen C

EXPERIMENTAL

Regimen C: 2-Drug Combination Chemotherapy with Drug Modulation followed, as indicated, by Radiotherapy.

Biological: Filgrastim; Drug: Cisplatin; Drug: Fluorouracil; Drug: Leucovorin calcium; Drug: Pentamidine; Drug: Trimethoprim-Sulfamethoxazole; Drug: Zidovudine (AZT); Radiation: Radiation Therapy

Interventions

Bleomycin Sulfate BIOLOGICAL

Also known as: Blenoxane, BLM

Regimen A

Filgrastim BIOLOGICAL

Also known as: G-CSF, Neupogen

Regimen B; Regimen C

Cisplatin DRUG

Also known as: Platinol, Plationol-AQ, CDDP

Regimen C

Cyclophosphamide DRUG

Also known as: Cytoxan, Neosar

Regimen A

Cytarabine DRUG

Also known as: Ara-C, Cytosar, DepoCyt, Cytarabine arabinosine hydrochloride

Regimen B

Doxorubicin Hydrochloride (DOX) DRUG

Also known as: Adriamycin PFS, Adriamycin RDF

Regimen A; Regimen B

Etoposide DRUG

Also known as: VePesid

Regimen B

Fluorouracil DRUG

Also known as: 5-FU, Adrucil, Efudex, 5-Fluorouracil

Regimen C

Ifosfamide DRUG

Also known as: Ifex

Regimen B

Leucovorin calcium DRUG

Also known as: Citrovorum, Wellcovorin

Regimen C

Methotrexate DRUG

Regimen B

Methylprednisolone DRUG

Also known as: Depo-Medrol, Medrol, Solu-Medrol

Regimen B

Pentamidine DRUG

Also known as: Pentam-300

Regimen A; Regimen B; Regimen C

Prednisone DRUG

Regimen A

Trimethoprim-Sulfamethoxazole DRUG

Also known as: SMX, Bactrim, Cotrim, Septra, Sulfamethoprim, Sulfatrim, Sulfoxaprim, Trisulfam, Uroplus, Co-trimoxazole, SMX-TMP

Regimen A; Regimen B; Regimen C

Vincristine Sulfate DRUG

Regimen A

Zidovudine (AZT) DRUG

Also known as: Retrovir

Regimen A; Regimen B; Regimen C

Radiation Therapy RADIATION

Also known as: RT, Radiotherapy

Regimen A; Regimen B; Regimen C

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma

Interventions

Bleomycin; Filgrastim; Granulocyte Colony-Stimulating Factor; Cisplatin; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Fluorouracil; Ifosfamide; Leucovorin; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pentamidine; Prednisone; Trimethoprim, Sulfamethoxazole Drug Combination; Vincristine; Cortodoxone; Zidovudine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Uracil; Pyrimidinones; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamidines; Amidines; Pregnadienediols; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Sulfones; Sulfur Compounds; Trimethoprim; Drug Combinations; Pharmaceutical Preparations; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnenediones; Pregnenes; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thymidine; Dideoxynucleosides; Deoxyribonucleosides; Therapeutics

Study Officials

• Peter W. McLaughlin, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: October 5, 2004
• Study Start: June 1, 1993
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (2)