Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
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| ClinicalTrials.gov Identifier: NCT00000801 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 1, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin HIV Infections | Drug: Filgrastim Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 33 participants |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma |
| Actual Study Completion Date : | April 1998 |
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT00000801
| United States, California | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Massachusetts | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| ECOG Data Management Office | |
| Brookline, Massachusetts, United States, 02146 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Study Chair: | Krigel RL | ||
| Study Chair: | Von Roenn J |
Publications:
| ClinicalTrials.gov Identifier: | NCT00000801 History of Changes |
| Other Study ID Numbers: |
ACTG 252 ECOG E 1493 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 1, 2012 |
| Last Verified: | October 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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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 |
Additional relevant MeSH terms:
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Lymphoma HIV Infections Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Dexamethasone Dexamethasone acetate Cyclophosphamide Doxorubicin Liposomal doxorubicin Cytarabine Vincristine BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |