Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• filgrastim — BIOLOGICAL
  subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
• ifosfamide — DRUG
  V over 24 hours on days 1-4
• vinorelbine tartrate — DRUG
  IV over 6-10 minutes on days 1 and 5.

Study Details

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.

Key Dates

Start date

May 31, 2001

Status verified

Jul 2013

Primary completion

Jul 31, 2005

Completion

Mar 31, 2012

Study Design

Enrollment

66 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ifosfamide, vinorelbine, filgrastim)
  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.

Primary Outcome Measure

Overall response rate [ Time Frame: After 2 cycles ]

Locations (101)

Find similar trials in Birmingham, AL

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