A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-11

Study Completion Date

2010-12-22

Brief Summary

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This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with Good Clinical Practices. This study will evaluate the safety, tolerability and dose-finding of robatumumab when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C).

The primary study hypothesis is that robatumumab can be safely administered in combination with chemotherapy regimens in pediatric participants with solid tumors.

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Detailed Description

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Conditions

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Neoplasms Solid Tumors Bone Cancer Kidney Tumor Neuroblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Temozolomide+Irinotecan+Robatumumab

Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Irinotecan

Intervention Type DRUG

Robatumumab

Intervention Type BIOLOGICAL

Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab

Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Vincristine

Intervention Type DRUG

Robatumumab

Intervention Type BIOLOGICAL

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Ifosfamide+Etoposide+Robatumumab

Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Ifosfamide

Intervention Type DRUG

Robatumumab

Intervention Type BIOLOGICAL

Etoposide

Intervention Type DRUG

Interventions

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Temozolomide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Irinotecan

Intervention Type DRUG

Robatumumab

Intervention Type BIOLOGICAL

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be \<= 21 years of age (older participants may be allowed on study on a case-by-case basis); may be of either sex, and of any race/ethnicity.
* Must have histologic confirmation of the advanced solid tumor, except for brainstem tumors.
* Must have Karnofsky performance score of \>=50 (if participant is \>16 years of age) or a Lansky score of \>50 (if participant is \<=16 years of age).
* Must have adequate organ function during Screening.
* Must be able to adhere to dose and visit schedules.

Exclusion Criteria

* Must not have a history of another malignancy.
* Must not have uncontrolled diabetes mellitus.
* Must not have persistent, unresolved common terminology criteria for adverse events (CTCAE) Grade \>=2 drug-related toxicity associated with previous treatment.
* Must not have known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications.
* If female, must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at Screening.
* Must not be known to have human immunodeficiency virus (HIV) infection or known HIV-related malignancy.
* Must not be known to have active Hepatitis B, or Hepatitis C.
* Must not have any serious or uncontrolled infection.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No