Lymphoma, Non-HodgkinNCT00000703
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
A study testing Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
Trial summary
To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, HIV Infections
- What is being tested?
- Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride
- How many people
- 45 participants
- Where
- 14 sitesUnited States
- Study dates
- Start not givento Mar 1990
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 30Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Rochester Medical Center
Rochester, New York, 14642
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Julio Arroyo
West Columbia, South Carolina, 29169
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
About this study
To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma.
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.
Read the detailed description
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.
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Being tested
- Bleomycin sulfate, Vincristine sulfate, Doxorubicin hydrochloride, Cyclophosphamide, Allopurinol
- Keywords
- Vincristine, Lymphoma, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Drug Therapy, Combination, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Zidovudine, Bleomycin
- Medical subject headings
- Lymphoma, Non-Hodgkin, HIV Infections, Lymphoma, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin sulfateDrug
CyclophosphamideDrug
AllopurinolDrug
MethotrexateDrug
CytarabineDrug
ZidovudineDrug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMar 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Levine A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000703
- Sponsor's protocol ID
- ACTG 008
- Other IDs
- 10984
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Saag MS, Emini EA, Laskin OL, Douglas J, Lapidus WI, Schleif WA, Whitley RJ, Hildebrand C, Byrnes VW, Kappes JC, et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 Working Group. N Engl J Med. 1993 Oct 7;329(15):1065-72. doi: 10.1056/NEJM199310073291502.
PubMed 7690462Levine AM, Wernz JC, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett JM, Rarick MU, Walsh C, Kahn J, et al. Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance in AIDS-related lymphoma. A prospective multi-institutional trial. JAMA. 1991 Jul 3;266(1):84-8.
PubMed 1710673ICDB/89653727. Levine AM, et al. Low dose chemotherapy with CNS prophylaxis and zidovudine (AZT) maintenance for aids-related lymphoma: preliminary results of a multi-institutional study. Proc Annu Meet Am Soc Clin Oncol. 1989 8:A18
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
- ClinicalTrials.gov ID
- NCT00000703
- Acronym / sponsor ID
- ACTG 008
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Keywords
- Vincristine, Lymphoma, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Drug Therapy, Combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1990 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ibuprofen.
- Standard antiemetic agents.
- Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection.
- Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase.
Key exclusion criteria (30 listed)
- 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.
- Corticosteroids.
- Aspirin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bleomycin sulfate | Drug | – |
| Vincristine sulfate | Drug | – |
| Doxorubicin hydrochloride | Drug | – |
| Cyclophosphamide | Drug | – |
| Allopurinol | Drug | – |
| Methotrexate | Drug | – |
| Cytarabine | Drug | – |
| Leucovorin calcium | Drug | – |
| Zidovudine | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 7690462Saag MS, Emini EA, Laskin OL, Douglas J, Lapidus WI, Schleif WA, Whitley RJ, Hildebrand C, Byrnes VW, Kappes JC, et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 Working Group. N Engl J Med. 1993 Oct 7;329(15):1065-72. doi: 10.1056/NEJM199310073291502.
- Background: PubMed 1710673Levine AM, Wernz JC, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett JM, Rarick MU, Walsh C, Kahn J, et al. Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance in AIDS-related lymphoma. A prospective multi-institutional trial. JAMA. 1991 Jul 3;266(1):84-8.
- BackgroundICDB/89653727. Levine AM, et al. Low dose chemotherapy with CNS prophylaxis and zidovudine (AZT) maintenance for aids-related lymphoma: preliminary results of a multi-institutional study. Proc Annu Meet Am Soc Clin Oncol. 1989 8:A18
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levine A study chair
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.