A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors

NCT00024284

Unspecified Childhood Solid Tumor, Protocol Specific

COMPLETED PHASE1

Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors

NCT01518413

Rhabdomyosarcoma and Other Soft Tissue Sarcomas Ewing's Sarcoma Family of Tumors Osteosarcoma +2 more

COMPLETED PHASE1

A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

NCT00990912

Pediatric Solid Tumors

COMPLETED PHASE1/PHASE2

Irinotecan in Treating Children With Refractory Solid Tumors

NCT00004078

Childhood Central Nervous System Germ Cell Tumor Childhood Choroid Plexus Tumor Childhood Craniopharyngioma +18 more

COMPLETED PHASE2

Irinotecan in Treating Children With Refractory or Progressive Solid Tumors

NCT00016861

Unspecified Childhood Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Group Type EXPERIMENTAL

carboplatin + irinotecan

Intervention Type DRUG

Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.

Arm B

Group Type ACTIVE_COMPARATOR

irinotecan

Intervention Type DRUG

Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carboplatin + irinotecan

Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.

Intervention Type DRUG

irinotecan

Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paraplatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children 1-21 years of age
* confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known
* at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy
* no more than 3 prior chemotherapies
* no symptomatic brain metastases

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No