SWOG-9320 Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

NCT00002571 | Completed Phase 2

• 3 other identifiers: CDR0000063620SWOG-9320U10CA032102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 85

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Antiviral therapy may be effective treatment for AIDS-related lymphoma. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic 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)

• Response

  every 3 months while on protocol treatment

Study Arms (1)

ProMACE-CytaBOM + G-CSF

EXPERIMENTAL

6 cycles of 21 days each of ProMACE-CytaBOM (cyclophosphamide 490 mg/m\^2 on day 1, doxorubicin 19 mg/m\^2 on day 1, etoposide 90 mg/m\^2 on day 1, cytarabine 225 mg/m\^2 on day 8, bleomycin 5 u/m\^2 on day 8, methotrexate 90 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, vincristine 1.4 mg/m\^2 on day 8, prednisone 60 mg/m\^2 on days 1-14, allopurinol 300 mg on days 1-21 of cycle 1 and days 1-8 of cycle 2 only) plus 1 double strength tablet TMP/SMX 3 days a week plus G-CSF 5 ug/kg on days 9-20. Patients also receive intrathecal cytarabine 30 mg/m\^2 (BM positive: 5 doses spaced evenly during 1st 2 cycles, then on day 1 of cycles 3-6; CSF cytology positive: 5 doses spaced evenly during 1st cycle, then on day 1 of cycles 2-6; BM and CSF negative: 5 doses spaced evenly within 1 month of completion of cycle 6). All patients with CR or PR after systemic therapy and IT cytarabine receive 2400 cGy RT to the whole brain in 12 fractions.

Biological: bleomycin sulfate; Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: leucovorin calcium; Drug: methotrexate; Drug: prednisone; Drug: trimethoprim-sulfamethoxazole; Drug: vincristine sulfate; Radiation: radiation therapy; Drug: Intrathecal cytarabine

Interventions

bleomycin sulfate BIOLOGICAL

5u/m2 IV Q21days x 6 cycles

ProMACE-CytaBOM + G-CSF

filgrastim BIOLOGICAL

5ug/kg SC, Days 9-20, Q 21 days x 6 cycles

Also known as: G-CSF

ProMACE-CytaBOM + G-CSF

cyclophosphamide DRUG

490 mg/m2 IV Q 21 days x 6 cycles

ProMACE-CytaBOM + G-CSF

cytarabine DRUG

225 mg/m2 IV Q 21 days x 6 cycles

ProMACE-CytaBOM + G-CSF

doxorubicin hydrochloride DRUG

19 mg/m2 IV Q 21 days x 6 cycles

ProMACE-CytaBOM + G-CSF

etoposide DRUG

90 mg/m2 IV Q 21 days x 6 cycles

Also known as: VP-16

ProMACE-CytaBOM + G-CSF

leucovorin calcium DRUG

25 mg/m2 po 24 hours after methotrexate Q 6 hours x 4 doses for 6 cycles.

ProMACE-CytaBOM + G-CSF

methotrexate DRUG

90 mg/m2 IV, Q 21 days x 6 cycles.

ProMACE-CytaBOM + G-CSF

prednisone DRUG

60 mg/m2 po QD x 14days for 6 cycles

ProMACE-CytaBOM + G-CSF

trimethoprim-sulfamethoxazole DRUG

1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles

Also known as: TMP/SMX

ProMACE-CytaBOM + G-CSF

vincristine sulfate DRUG

1.4 mg/m2 IV Q 21 Days x 6 cycles

ProMACE-CytaBOM + G-CSF

radiation therapy RADIATION

All patients achieving a CR or PR following systemic therapy and IT Ara-C, will receive 2,400 cGy in two hundred cGy fractions to the whole brain. Fields should adequately encompass all meningeal surfaces.

ProMACE-CytaBOM + G-CSF

Intrathecal cytarabine DRUG

If initial bone marrow positive: Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first two cycles of therapy. Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If initial CSF cytology positive: Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first cycle of therapy. If CSF negative after above, Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If CSF positive after initial five doses of Ara-C, IT MTX 12 mg per dose x 5 doses should be given spaced evenly during the second cycle of therapy. If initial bone marrow and CSF negative: Ara-C 30 mg/m2 IT per dose x 5 doses to be given spaced evenly within 1 month of completion of systemic therapy.

Also known as: IT Ara-C

ProMACE-CytaBOM + G-CSF

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven intermediate or high grade non-Hodgkin's lymphoma of one of the following histologies: Follicular, predominantly large cell Diffuse, small cleaved cell Diffuse mixed, small and large cell Diffuse, large cell (cleaved or noncleaved) Immunoblastic, large cell Small noncleaved cell, Burkitt's or non-Burkitt's No lymphoblastic lymphoma Prior diagnosis of AIDS or HIV positivity required Confirmation of HIV antibody status by Western blot mandatory Bidimensionally measurable or evaluable disease No primary CNS lymphoma Concurrent registration on protocol SWOG-8947 (central serum repository) required PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Hematopoietic: Absolute neutrophil count at least 500/mm3 Platelet count at least 75,000/mm3 Hepatic: AST no greater than 1.5 times normal Alkaline phosphatase no greater than 1.5 times normal LDH no greater than 1.5 times normal PT/PTT normal Renal: Creatinine no greater than 2.0 times normal Creatinine clearance at least 60 mL/min Cardiovascular: No serious abnormalities on EKG No history of severe coronary artery disease No history of cardiomyopathy, congestive heart failure, or arrhythmia Other: No active uncontrolled infection No active second malignancy within 5 years except adequately treated nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for lymphoma

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (85)

MBCCOP - University of South Alabama

Mobile, Alabama, 36688, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40511-1093, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-1329, United States

Location

Texas Tech University Health Science Center

Lubbock, Texas, 79423, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78284, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Bleomycin; Filgrastim; Granulocyte Colony-Stimulating Factor; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Leucovorin; Methotrexate; Prednisone; Trimethoprim, Sulfamethoxazole Drug Combination; Vincristine; 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; 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; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; 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; Therapeutics

Study Officials

• Lode J. Swinnen, MD

  Loyola University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 24, 2004
• Study Start: June 1, 1994
• Primary Completion: November 1, 2003
• Study Completion: July 1, 2011
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (85)