Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-A… (NCT00641381) | Clinical Trial Compass
CompletedPhase 1
Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma
United States25 participantsStarted 2000-05-10
Plain-language summary
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells that were collected from the patient's blood are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine, etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it works in treating patients with HIV-associated lymphoma.
Who can participate
Age range
10 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV seropositive at or before the time of lymphoma diagnosis
* Subjects must be on a multi-drug regimen (excluding azidothymidine) to maintain HIV viral load less than 50,000 Gc/mL; if the CD4 count at enrollment is less than 100 then the viral load should be less than 10,000 by reverse transcriptase polymerase chain reaction (Rt-PCR); if the CD4 count is greater than 100/mm\^3 prior to the start of any lymphoma chemotherapy and is greater than 100/mm\^3 for at least 3 months then the viral load must be less than 150,000 gc/ml and clinically stable; if no pre-chemotherapy CD4 counts are available, then viral load alone will be used from enrollment
* The known hematopoietic toxicity of AZT (zidovudine) prohibits its use pre-transplant during stem cell collection and during the immediate period of engraftment post-transplant; resumptions of AZT should not begin until there is evidence of stable engraftment; therefore, AZT should not be resumed until at least 2 months after last blood product support is used; since platelet support continues until approximately day +14 days in our experience with acquired immune deficiency syndrome (AIDS) patients transplanted date, AZT will be prohibited until at least 2 months after transplant; therefore, if the anti-HIV drug combination needs to be modified then AZT can be part of the new regimen
* Karnofsky performance status \>= 70%
* Biopsy proven intermediate grade or high-grade Non-Hodgkin's lymphoma, (working form…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a combination of carmustine, etoposide, and cyclophosphamide followed by a stem cell transplant specifically for HIV-associated lymphoma — given my situation, is this kind of high-dose chemotherapy with a transplant something my care team thinks would even be worth considering for me?
2Since this was a Phase 1 trial that has already completed, what did researchers learn about the safety and toxicity of this regimen, and does my doctor have access to any published results I should know about?
3The trial measured how many days it took for the stem cells to successfully engraft — what does that recovery timeline actually look like day-to-day, and how would managing my HIV treatment alongside that process complicate things?
4Because this was a Phase 1 study focused mainly on safety and feasibility rather than proving the treatment works, how does that limit what we can conclude about whether this approach actually improves outcomes for HIV-associated lymphoma?
5Are there standard treatments or newer approaches for HIV-associated lymphoma that my doctor would recommend exploring before considering an intensive regimen like the one used in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope
Timeframe: Day 100 post stem cell reinfusion
2
Feasibility and treatment-associated toxicity of this regimen