Clinical trial · Interventional
Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment
A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory
- 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.
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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed Hodgkin's disease OR * Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL) * No prior diagnosis of low-grade NHL * No histologic evidence of transformation from indolent to aggressive histology * Bidimensionally measurable disease that is clinically or radiologically documented * Bone lesions not considered bidimensionally measurable * Lymph nodes at least 1.5 cm by 1.5 cm OR * Other non-nodal lesions at least 1 cm by 1 cm * Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin) * No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal: * Creatinine less than 1.6 mg/dL Cardiovascular: * No significant cardiac dysfunction or cardiovascular disease Other: * HIV negative * No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No other serious illness or medical condition that would preclude study * No active uncontrolled bacterial, fungal, or viral infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior stem cell transplantation * No concurrent monoclonal antibody therapy * No concurrent growth factors during the first course of study Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior IV chemotherapy * No prior cisplatin or gemcitabine * No prior high-dose chemotherapy * No other concurrent cytotoxic therapy Endocrine therapy: * No concurrent corticosteroids, except for physiologic replacement Radiotherapy: * No prior radiotherapy to more than 25% of functioning bone marrow * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * At least 2 weeks since prior major surgery Other: * No other concurrent anti-cancer therapy or experimental therapy
References
Publications (2)
- RESULTCrump M, Baetz T, Couban S, Belch A, Marcellus D, Howson-Jan K, Imrie K, Myers R, Adams G, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R. Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B-cell non-Hodgkin lymphoma: a Phase II study by the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). Cancer. 2004 Oct 15;101(8):1835-42. doi: 10.1002/cncr.20587. PMID 15386331
- RESULTBaetz T, Belch A, Couban S, Imrie K, Yau J, Myers R, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R, Crump M. Gemcitabine, dexamethasone and cisplatin is an active and non-toxic chemotherapy regimen in relapsed or refractory Hodgkin's disease: a phase II study by the National Cancer Institute of Canada Clinical Trials Group. Ann Oncol. 2003 Dec;14(12):1762-7. doi: 10.1093/annonc/mdg496. PMID 14630682