Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lym… (NCT00070304) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma
United States, Australia, Canada33 participantsStarted 2004-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, 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: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.
Who can participate
Age range
30 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 Hodgkin's lymphoma\* with any of the following histologies:
* Not otherwise specified (NOS)
* Mixed cellularity NOS
* Lymphocytic depletion
* NOS
* Diffuse fibrosis
* Reticular
* Lymphocytic predominance
* NOS
* Diffuse
* Nodular
* Paragranuloma
* Granuloma
* Sarcoma
* Nodular sclerosis
* Cellular phase
* NOS
* Lymphocytic predominance
* Mixed cellularity
* Lymphocytic depletion NOTE: \*Disease metastatic to bone marrow with granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable for hematological toxicity
* Measurable disease by clinical or radiographic criteria
* Relapsed or refractory to conventional therapy
* Received at least 2 prior cytotoxic chemotherapy regimens
* No stage IA or IIA nodal disease previously treated with any of the following:
* Radiotherapy only
* No more than 4 courses of prior chemotherapy
PATIENT CHARACTERISTICS:
Age
* 30 and under
Performance status
* Karnofsky 50-100% (over 16 years of age)
* Lansky 50-100% (16 and under) OR
* ECOG 0-2
Life expectancy
* At least 8 weeks
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3 (transfusion independent, defined as ≥ 3 days since prior platelet transfusion)
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
Renal
* Creatinine clearance or radioisotope glomeru…
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.