Completed

Phase 2
Age: 16Years +
All Genders
ID00000801

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-11-01

33

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 7 locations

1

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

2

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

3

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

Status Unknown

4

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States, 02215

Status Unknown

5

ECOG Data Management Office

Brookline, Massachusetts, United States, 02146

Status Unknown

6

Mount Sinai Med Ctr

New York, New York, United States, 10029

Status Unknown

7

Julio Arroyo

West Columbia, South Carolina, United States, 29169

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06.

C Schultz, C Scott, W Sherman...

https://pubmed.ncbi.nlm.nih.gov/8636771