Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• amifostine trihydrate — DRUG
  Given IV
• pharmacological study — OTHER
  Correlative studies

Study Details

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy.

Key Dates

Start date

Dec 31, 1999

Status verified

Jul 2013

Primary completion

Mar 31, 2003

Study Design

Enrollment

30 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cisplatin, irinotecan, amifostine)
  Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin.

Primary Outcome Measure

MTD defined as that dose level immediately below the dose level at which 2 patients out of 3 to 6 patients experienced dose-limiting toxicity using Common Toxicity Criteria version 2.0 [ Time Frame: 6 weeks ]

Locations (1)

Find similar trials in Arcadia, CA

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  Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina