Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease
NCT00006029CI-TRIAL-00023074completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- vinorelbine + gemcitabine + doxorubicin - higher doses
- description
- Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome. Patients are followed every 6 months for 2 years and then annually for 6 years.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pegylated liposomal doxorubicin hydrochloride
- Drug: vinorelbine tartrate
- type
- EXPERIMENTAL
- label
- vinorelbine + gemcitabine + doxorubicin - lower doses
- description
- Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome. Patients are followed every 6 months for 2 years and then annually for 6 years.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pegylated liposomal doxorubicin hydrochloride
- Drug: vinorelbine tartrate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy * Core biopsy is acceptable if adequate tissue is obtained for primary diagnosis and immunophenotyping * Bone marrow biopsy is not acceptable as sole means of diagnosis * Measurable disease * Tumor mass greater than 1 cm PATIENT CHARACTERISTICS: Age: * Any age Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL unless history of Gilbert's disease * AST no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * LVEF at least 45% by MUGA (for patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m\^2) Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior gemcitabine, vinorelbine, or doxorubicin HCl liposome * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormones except for nondisease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure * No concurrent dexamethasone or other steroidal antiemetics
References
Publications (3)
- RESULTLai R, Bartlett NL, Mackey JR, Jung SH, Johnson JL, Cook JR, Jones D, Cass CE, Young JD, Said J, Cheson B, Hsi ED. High expression of nucleoside transporter protein hENT1 in Reed-Sternberg cells is associated with treatment failure in relapsed/refractory Hodgkin lymphoma patients treated with gemcitabine, vinorelbine and liposomal doxorubicin - a CALGB 59804 correlative study. Leuk Lymphoma. 2008 Jun;49(6):1202-5. doi: 10.1080/10428190802094237. No abstract available. PMID 18452103
- RESULTBartlett NL, Niedzwiecki D, Johnson JL, Friedberg JW, Johnson KB, van Besien K, Zelenetz AD, Cheson BD, Canellos GP; Cancer Leukemia Group B. Gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD), a salvage regimen in relapsed Hodgkin's lymphoma: CALGB 59804. Ann Oncol. 2007 Jun;18(6):1071-9. doi: 10.1093/annonc/mdm090. Epub 2007 Apr 10. PMID 17426059
- RESULTBartlett N, Niedzwiecki D, Johnson J, et al.: A phase I/II study of gemcitabine, vinorelbine, and liposomal doxorubicin for relapsed Hodgkin's disease: preliminary results of CALGB 59804. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2275, 566, 2003.