LymphomaPhase 2NCT00003388
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Lymphoma, run by Eastern Cooperative Oncology Group at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, cyclophosphamide and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Jul 1999to Apr 2003
- Phase
- Phase 2
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed AIDS-related non-Hodgkin's lymphoma of the intermediate or high grade histologic types Anaplastic large cell lymphoma allowed Must be HIV positive Must have at least one objective measurable or evaluable disease parameter No parenchymal CNS involvement by lymphoma (meningeal lymphoma allowed) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: (Except patients with lymphomatous marrow involvement) Absolute neutrophil count at least 1000/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 5.0 mg/dL Renal: Creatinine less than 3.0 mg/dL Cardiovascular: Patients with history of heart disease, evidence of congestive heart failure, radiographic evidence of cardiomegaly, or electrocardiographic evidence of a prior myocardial infarction must have LVEF at least at lower limit of normal Neurologic: No grade 3 or greater peripheral neuropathy Other: No prior or concurrent malignancy other than Kaposi's sarcoma, curatively treated basal cell or squamous cell carcinoma of the skin, or curatively treated carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No history of sensitivity to E. coli-derived proteins
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 5 days since interferon therapy Chemotherapy: No prior cytotoxic chemotherapy except for mucocutaneous Kaposi's sarcoma At least 12 months since cytotoxic chemotherapy for Kaposi's sarcoma Endocrine therapy: Prior steroids allowed No concurrent steroid therapy greater than 5 mg prednisone (or equivalent) per day Radiotherapy: No prior radiotherapy except for mucocutaneous Kaposi's sarcoma Surgery: Not specified Other: No concurrent zidovudine (AZT) Concurrent antiretroviral medications other than AZT allowed
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
Stanford University Medical Center
Stanford, California, 94305-5408
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
About this study
Official title: A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS-related lymphoma.
Read the detailed description
OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen, Doxil-CVP, in this patient population. III. Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the incidences and types of opportunistic infections in this patient population.
OUTLINE: Patients are stratified according to disease characteristics. All patients receive a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum of 8 courses are administered. Patients are removed from the study for progressive disease, stable disease after 4 courses, a life threatening infection that would delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- filgrastim, cyclophosphamide, cytarabine, methotrexate, pegylated liposomal doxorubicin hydrochloride
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma, anaplastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cyclophosphamideDrug
cytarabineDrug
methotrexateDrug
pegylated liposomal doxorubicin hydrochlorideDrug
prednisoneDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2003 (estimated)
- Study start26 Jul 1999
- Primary completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Matthew D. Volm, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003388
- Sponsor's protocol ID
- CDR0000066385
- Other IDs
- E-3D97
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
- ClinicalTrials.gov ID
- NCT00003388
- Acronym / sponsor ID
- CDR0000066385
- Conditions
- Lymphoma
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma, anaplastic large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jul 1999 (actual)
- Primary completion
- Apr 2003 (actual)
- First posted
- 2 Dec 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS-related lymphoma.
Detailed description
OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen, Doxil-CVP, in this patient population. III. Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the incidences and types of opportunistic infections in this patient population.
OUTLINE: Patients are stratified according to disease characteristics. All patients receive a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum of 8 courses are administered. Patients are removed from the study for progressive disease, stable disease after 4 courses, a life threatening infection that would delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| methotrexate | Drug | – |
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
| prednisone | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
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 22 Jun 2023.
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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.
Matthew D. Volm, MD study chair
NYU Langone Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Lymphoma, run by Eastern Cooperative Oncology Group at 5 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?
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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 22 Jun 2023.