Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy

Not Recruiting

Trial ID: NCT00381940


This phase II trial studies the side effects and efficacy of bortezomib with ifosfamide and vinorelbine in children and young adults with Hodgkin's lymphoma that was recurrent or did not respond to previous therapy. Bortezomib is an inhibitor of protein degradation. Bortezomib degrades short-lived regulatory proteins in the cell, and has been reported to increase the tumor cells. Bortezomib may increase the effectiveness of ifosfamide and vinorelbine (two standard drugs given to children with Hodgkin Lymphoma that has come back after initial treatment) by making cancer cells more sensitive to effectiveness of standard chemotherapy by preventing anti-death responses in these drugs. Giving bortezomib together with ifosfamide and vinorelbine tartrate should kill more cancer cells than are killed with ifosfamide and vinorelbine alone.

Official Title

A Phase II Study of Bortezomib (Velcade, PS-341) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease

Stanford Investigator(s)


Inclusion Criteria:

   - Histologically confirmed Hodgkin's lymphoma at time of relapse or disease progression,
   meeting all of the following criteria:

      - Stage I-IV disease

      - No morphologically unclassifiable disease

   - Meets 1 of the following criteria:

      - Mixed cellularity

      - Lymphocytic depletion (LD)

      - LD, diffuse fibrosis

      - LD, reticular

      - Lymphocyte predominance (LP)

      - LP, diffuse

      - LP, nodular

      - Nodular sclerosis (NS)

      - NS, cellular phase

      - NS, lymphocytic predominance

      - NS, mixed cellularity

      - NS, LD

      - Not otherwise specified

   - Primary refractory disease OR disease in first relapse, except for the following:

      - Patients who achieved a complete response after treatment on protocol
      COG-AHOD0431 who experience a biopsy-proven recurrence after doxorubicin
      hydrochloride, vincristine, prednisone, and cyclophosphamide without
      involved-field radiotherapy

      - Patients on the observation-only arm of protocol COG-AHOD0431

   - Any measurable, focal mass lesion of a visceral organ (e.g., liver, spleen, or kidney)

   - Patients with metastatic disease to bone marrow and granulocytopenia, anemia, and/or
   thrombocytopenia are allowed provided both of the following criteria are met:

      - Platelet count ≥ 20,000/mm³ (platelet transfusion allowed)

      - Hemoglobin ≥ 8 g/dL (packed red blood cell transfusion allowed)

   - Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lanksy
   PS 60-100% (for patients =< 16 years of age)

   - Life expectancy >= 2 months

   - Absolute neutrophil count >= 1,000/mm^3

   - Platelet count >= 75,000/mm^3 (transfusion independent) (for patients with no bone
   marrow involvement)

   - Creatinine =< 1.5 times upper limit of normal (ULN)

   - Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min/1.73 m^2

   - AST and ALT =< 2.5 times ULN

   - Bilirubin =< 1.5 times ULN

   - Shortening fraction >= 27% by echocardiogram OR LVEF >= 50% by gated radionuclide

   - Patients with a seizure disorder are eligible if on a nonenzyme-inducing
   anticonvulsant and seizures are well controlled

   - No CNS toxicity > grade 2

   - No serious intercurrent illnesses

   - No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any
   component of the study drugs

   - No peripheral neuropathy > grade 1

   - No known hypersensitivity to bortezomib, boron, or mannitol

   - No other concurrent chemotherapy or immunomodulating agents (including steroids)

      - Concurrent corticosteroids allowed for treatment or prophylaxis of anaphylactic

      - No dexamethasone or aprepitant as an antiemetic

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - Recovered from prior therapy

   - No prior bortezomib or other proteasome inhibitors

   - At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas)

   - More than 14 days since prior investigational drugs

   - No concurrent enzyme inducing anticonvulsants that alter p450 metabolism, including
   phenytoin, carbamazepine, phenobarbital, or other anticonvulsants

      - Benzodiazepine or gabapentin allowed


biological: filgrastim

drug: ifosfamide

drug: bortezomib

drug: vinorelbine tartrate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina

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