A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma (NCT00081809) | Clinical Trial Compass
CompletedPhase 2
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
United States35 participantsStarted 2000-03
Plain-language summary
Primary Objectives:
* To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
* the rate of complete and partial responses
* the time to progression.
Secondary Objectives:
* To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
* To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
* To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
* To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
Who can participate
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:
* Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
* Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
* Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
* A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
* Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
* Life expectancy of at least 16 weeks;
* Zubrod performance status of less then or equal to 2;
* Adequate bone marrow function;
* Adequate hepatic function;
* Adequate renal function;
* Signed written informed consent;
* Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator;
* Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating;
* Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up;
* Electrocardiogram if none performed in the prior six months;
* Patients must have no chemotherapy, immunoth…
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.