Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Au… (NCT00101101) | Clinical Trial Compass
CompletedPhase 2
Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
United States43 participantsStarted 2004-07
Plain-language summary
RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination chemotherapy may be a more effective treatment for mantle cell lymphoma.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II, stage III, or stage IV mantle cell lymphoma.
Who can participate
Age range
18 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed mantle cell lymphoma
* Stage II, III, or IV disease
* Relapsed or de novo disease
* No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
* Not specified
Hematopoietic
* White blood count (WBC) \> 3,000/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hematocrit \> 25%
* Hemoglobin \> 8 g/dL
Hepatic
* Bilirubin \< 2.0 mg/dL
Renal
* Creatinine \< 2.0 mg/dL OR
* Creatinine clearance \> 60 mL/min
Immunologic
* No serious ongoing infection
* No known HIV infection
* No other pre-existing immunodeficiency condition
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No other concurrent immunotherapy
Chemotherapy
* More than 4 weeks since prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* More than 4 weeks since prior steroids
* No concurrent corticosteroids except as replacement doses in patients who are hypoadrenal
Radiotherapy
* More than 2 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No other concurrent immunosuppressive therapy
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Rate of Immunological Response to Vaccination
Timeframe: 4 months per participant
Trial details
NCT IDNCT00101101
SponsorH. Lee Moffitt Cancer Center and Research Institute