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Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Filgrastim
Vincristine sulfate
Doxorubicin hydrochloride
Cyclophosphamide
Cytarabine
Dexamethasone
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Vincristine, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Granulocyte Colony-Stimulating Factor, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Brain Neoplasms, Lymphoma, High-Grade, Lymphoma, Intermediate-Grade

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine. Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches. Antiretroviral agent available by therapy IND. MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3). Patients must have: HIV infection. Primary CNS lymphoma with NO systemic involvement. Prior Medication: Allowed: Prior corticosteroids. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin. Active uncontrolled infection. Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration. Active heart disease (congestive heart failure or heart block greater than first degree on EKG). Concurrent Medication: Excluded: Any investigational agent other than antiretroviral agents available by therapy IND. Patients with the following prior conditions are excluded: No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin. No new infectious complications within the past 2 weeks that require a change in antibiotics. History of myocardial infarction within the past 3 months. Prior Medication: Excluded: Prior chemotherapy other than for Kaposi's sarcoma.

Sites / Locations

  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • San Francisco Gen Hosp
  • Univ of Colorado Health Sciences Ctr
  • Beth Israel Deaconess - West Campus
  • ECOG Data Management Office
  • Mount Sinai Med Ctr
  • Julio Arroyo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 31, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000801
Brief Title
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Official Title
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Detailed Description
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma. Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, HIV Infections
Keywords
Vincristine, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Granulocyte Colony-Stimulating Factor, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Brain Neoplasms, Lymphoma, High-Grade, Lymphoma, Intermediate-Grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
33 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Filgrastim
Intervention Type
Drug
Intervention Name(s)
Vincristine sulfate
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine. Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches. Antiretroviral agent available by therapy IND. MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3). Patients must have: HIV infection. Primary CNS lymphoma with NO systemic involvement. Prior Medication: Allowed: Prior corticosteroids. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin. Active uncontrolled infection. Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration. Active heart disease (congestive heart failure or heart block greater than first degree on EKG). Concurrent Medication: Excluded: Any investigational agent other than antiretroviral agents available by therapy IND. Patients with the following prior conditions are excluded: No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin. No new infectious complications within the past 2 weeks that require a change in antibiotics. History of myocardial infarction within the past 3 months. Prior Medication: Excluded: Prior chemotherapy other than for Kaposi's sarcoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krigel RL
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Von Roenn J
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
ECOG Data Management Office
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02146
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8636771
Citation
Schultz C, Scott C, Sherman W, Donahue B, Fields J, Murray K, Fisher B, Abrams R, Meis-Kindblom J. Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol. 1996 Feb;14(2):556-64. doi: 10.1200/JCO.1996.14.2.556.
Results Reference
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Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

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