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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000801
First received: November 2, 1999
Last updated: October 31, 2012
Last verified: October 2012

November 2, 1999
October 31, 2012
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Complete list of historical versions of study NCT00000801 on ClinicalTrials.gov Archive Site
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Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Drug: Filgrastim
  • Drug: Vincristine sulfate
  • Drug: Doxorubicin hydrochloride
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Dexamethasone
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 1998
Not Provided

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000801
ACTG 252, ECOG E 1493
Not Provided
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National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Krigel RL
Study Chair: Von Roenn J
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP