Vaccine Therapy Plus Sargramostim Following Chemotherapy in Previously Untreated Aggressive Non-H… (NCT00004197) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
United StatesStarted 1999-06-25
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.
Who can participate
Age range
18 Years – 120 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:
* Histologically confirmed aggressive non-Hodgkin's lymphoma
* Diffuse mixed cell
* Diffuse large cell
* Immunoblastic Follicular large cell with more than 50% large cells
* Mantle cell
* Non-age adjusted International Prognostic Index 2-4
* Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy
* Must have adequate circulating lymphoma cells
* Over 18 years old
* Karnofsky 80-100%
* WBC greater than 2,500/mm3
* Platelet count greater than 100,000/mm3
* Hemoglobin at least 10 g/dL
* Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal
* Creatinine less than 2.0 mg/dL
* Fertile patients must use effective contraception during and for 6 months after the study
* At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent
* HIV negative
Exclusion Criteria:
* No CNS metastasis
* No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study
* No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing/negative pregnancy test
* No prior biologic therapy for lymphoma
* No prior cytotoxic chemotherapy for lymphoma
* No prior steroids for lymphoma
* No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent
* No prior radiotherapy for lymphoma
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.