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Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members


N/A
19 Years
69 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members


Other chemotherapies have been tried in patients with AIDS related lymphomas, but the
results have not been satisfactory. This study will show whether the combination of
chemotherapy, radiation, and AZT is more effective and less toxic than previously used
treatments.

All patients will receive combination chemotherapy and AZT. The combination chemotherapy
will be repeated every 3 to 4 weeks for a maximum total of 6 cycles. Each cycle will consist
of doxorubicin, bleomycin, cyclophosphamide, and vincristine on day 1, dexamethasone on days
1-5, and methotrexate on day 15. Patients with meningeal or bone marrow disease will receive
radiation and intrathecal cytarabine (ARA-C) while those without will receive ARA-C without
radiation. Patients with documented lymphomas in the central nervous system at initial
workup will start radiation as soon as possible and intrathecal ARA-C (t.i.w. until
cerebrospinal fluid is clear then every month for 1 year); patients with normal lumbar
puncture, brain scan, and bone marrow at first diagnosis will begin radiation on day 1 of
cycle 3 of chemotherapy. Lumbar punctures for evaluation will be done four times during the
first cycle, on days 1, 8, 21, and 28. AZT will be administered every 4 hours, 7 days a
week, beginning at the completion of combined chemotherapy, once the patient has achieved a
complete remission of the lymphoma, and continuing for 1 year.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Ibuprofen.

- Standard antiemetic agents.

- Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection.

- Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase.

Exclusion Criteria

Co-existing Condition:

The following patients will be excluded from the study:

- Patients with recurrent infection that may interfere with the planned protocol.

- Patients with a second active tumor other than nonmelanomatous skin cancer or
Kaposi's sarcoma.

- Patients with stage IE primary central nervous system lymphoma.

Concurrent Medication:

Excluded:

- Corticosteroids.

- Aspirin.

- Acetaminophen.

- Nonsteroidal anti-inflammatory drugs, except ibuprofen.

- Chemotherapy for infection associated with neutropenia.

- Zidovudine (AZT) for infection associated with neutropenia.

- Investigational therapies, except ganciclovir therapy for sight- or life-threatening
cytomegalovirus infection.

- AZT and methotrexate will be suspended during induction therapy with ganciclovir.

The following patients will be excluded from the study:

- Patients with recurrent infection that may interfere with the planned protocol.

- Patients with a second active tumor other than nonmelanomatous skin cancer or
Kaposi's sarcoma.

- Patients with stage IE primary central nervous system lymphoma.

Prior Medication:

Excluded:

- Zidovudine (AZT).

- Excluded within 2 weeks of study entry:

- Immunomodulating agents.

- Antiretroviral therapy prior to diagnosis of lymphoma.

Patients must demonstrate the following clinical and laboratory findings:

- Any stage of the disease, including stage I.

- Newly diagnosed, previously untreated high-grade lymphoma.

- Presence of measurable tumor parameter(s).

- Adequate hepatic, renal, and bone marrow function.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Levine A

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 008

NCT ID:

NCT00000703

Start Date:

Completion Date:

March 1990

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Vincristine
  • Lymphoma
  • Methotrexate
  • Cyclophosphamide
  • Cytarabine
  • Dexamethasone
  • Doxorubicin
  • Drug Therapy, Combination
  • Combined Modality Therapy
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents, Combined
  • Zidovudine
  • Bleomycin
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
George Washington Univ Med CtrWashington, District of Columbia  20037
Louisiana State Univ Med Ctr / Tulane Med SchoolNew Orleans, Louisiana  70112
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Univ of Massachusetts Med CtrWorcester, Massachusetts  01655
Mount Sinai Med CtrNew York, New York  10029
Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112