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

Conditions

• Adult Lymphocyte Depletion Hodgkin Lymphoma
• Adult Lymphocyte Predominant Hodgkin Lymphoma
• Adult Mixed Cellularity Hodgkin Lymphoma
• Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Adult Nodular Sclerosis Hodgkin Lymphoma
• Childhood Lymphocyte Depletion Hodgkin Lymphoma
• Childhood Lymphocyte Predominant Hodgkin Lymphoma
• Childhood Mixed Cellularity Hodgkin Lymphoma
• Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Childhood Nodular Sclerosis Hodgkin Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• Stage I Adult Hodgkin Lymphoma
• Stage I Childhood Hodgkin Lymphoma
• Stage II Adult Hodgkin Lymphoma
• Stage II Childhood Hodgkin Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage III Childhood Hodgkin Lymphoma
• Stage IV Adult Hodgkin Lymphoma
• Stage IV Childhood Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - 29 Years

Healthy Volunteers

Not accepted

Interventions

• ifosfamide — DRUG
  Given IV
• bortezomib — DRUG
  Given IV
• vinorelbine tartrate — DRUG
  Given IV
• filgrastim — BIOLOGICAL
  Given IV or SC

Study Details

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.

Key Dates

Start date

Jan 31, 2007

Status verified

Mar 2021

Primary completion

Jun 30, 2008

Completion

Dec 31, 2016

Study Design

Enrollment

26 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (enzyme inhibitor therapy, chemotherapy)
  Patients receive ifosfamide IV continuously over days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, bortezomib IV on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.

Primary Outcome Measure

Complete Response (CR) [ Time Frame: After 2 cycles of treatment ]

Locations (1)

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