Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
NCT00006760CI-TRIAL-00011500completedPhase 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, such as ifosfamide and vinorelbine, work in 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: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed 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 |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ifosfamide, vinorelbine, filgrastim)
- description
- Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.
- interventionNames
- Biological: filgrastim
- Drug: ifosfamide
- Drug: vinorelbine tartrate
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- After 2 cycles
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed refractory or relapsed Hodgkin's lymphoma * Mixed cellularity, not otherwise specified (NOS) * Lymphocytic depletion, NOS * Lymphocytic depletion, diffuse fibrosis * Lymphocytic depletion, reticular * Lymphocytic predominance, NOS * Lymphocytic predominance, diffuse * Lymphocytic predominance, nodular * Hodgkin's paragranuloma NOS * Hodgkin's granuloma * Hodgkin's sarcoma * Nodular sclerosis, NOS * Nodular sclerosis, cellular phase * Nodular sclerosis, lymphocytic predominance * Nodular sclerosis, mixed cellularity * Nodular sclerosis, lymphocytic depletion * Other (type not specified) * In first relapse * Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed * Not enrolled on POG-9426 unless there is an extranodal site of recurrence PATIENT CHARACTERISTICS: Age: * Under 30 at diagnosis Performance status: * Lansky 60-100% (for patients 16 years and under) * Karnofsky 60-100% (for patients over 16 years) Life expectancy: * At least 2 months Hematopoietic: * See Disease Characteristics * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion independent) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT or SGPT less than 2.5 times normal Renal: * Creatinine no greater than 1.5 times normal * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular: * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by gated radionuclide Other: * No other concurrent serious illness * No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunomodulating agents Chemotherapy: * At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent steroids * No concurrent corticosteroids (e.g., dexamethasone) Radiotherapy: * Recovered from prior radiotherapy Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.