A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2000-05-31

Brief Summary

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

A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at each dose level. MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity.

Each treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4.

Related Clinical Trials

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

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

SU5416 in Treating Children With Recurrent or Progressive Brain Tumors

NCT00006247

Brain and Central Nervous System Tumors

TERMINATED PHASE1

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

NCT02650401

Solid Tumors CNS Tumors

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors

NCT00019630

Childhood Soft Tissue Sarcoma Childhood Liver Cancer Bone Cancer +2 more

COMPLETED PHASE1

Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors

NCT05620862

Pediatric Solid Tumor

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

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

SU101 is a member of a novel class of antineoplastic agents, platelet-derived growth factor (PDGF) receptor inhibitors. Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas. A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent. In addition, we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response.

Conditions

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

Glioma Sarcoma

Study Design

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

Primary Study Purpose

TREATMENT

Interventions

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

SU101

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

DISEASE CHARACTERISTICS:

Histologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery.

PRIOR/CONCURRENT THERAPY:

Recovered from toxic affects of all prior therapy.

No investigational agent within past 2 weeks.

BIOLOGY THERAPY: Not specified.

CHEMOTHERAPY:

No myelosuppressive therapy within past 3 weeks.

No nitrosourea within past 6 weeks.

ENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks.

RADIOTHERAPY: Not specified.

SURGERY: Not specified.

PATIENT CHARACTERISTICS:

Age: 3 to 21.

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

HEMATOPOIETIC:

AGC greater than 1500/mm(3).

Hemoglobin greater than or equal to 8.0 g/dL percent.

Platelet count greater than 100,000/mm(3).

For patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3).

HEPATIC:

SGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal.

Bilirubin no less than or equal to 1.5 times upper limit of normal.

RENAL:

Ages 3-5 Creatinine no greater than 0.8 mg/dL.

Ages 5-10 Creatinine no greater than 1.0 mg/dL.

Ages 10-15 Creatinine no greater than 1.2 mg/dL.

Ages 16-21 Creatinine no greater than 1.5 mg/dL.

OTHER:

All patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study.

For patients with brain tumors who are over 18 years of age, a DPA should be signed.

Not pregnant or nursing.

Not allergic to etoposide.

No acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.

Eligible Sex

ALL

Accepts Healthy Volunteers

No