Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors

NCT00039481 | Completed Phase 1

• 4 other identifiers: NCI-2012-01872ADVL0211U01CA097452CDR0000069387
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy

Conditions

Cardiac Toxicity; Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxic effects and recommended phase II dose, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

  Up to day 21

• Change in pharmacokinetic behavior of this regimen

  Days 1 (pre-infusion), 5, 6, and 8 (end of infusion)

• Antitumor activity

  Up to day 21

• Biologic activity of oblimersen in mononuclear cells and tumor tissues, in terms of B-cell lymphoma 2 (bcl-2) and related protein expression

  Up to day 21

Study Arms (1)

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

EXPERIMENTAL

See detailed description.

Biological: oblimersen sodium; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: cyclophosphamide; Biological: filgrastim; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

oblimersen sodium BIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

dexrazoxane hydrochloride DRUG

Given IV

Also known as: Cardioxane, Savene, Totect, Zinecard

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

doxorubicin hydrochloride DRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (Oblimersen sodium, cytotoxic chemotherapy)

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists
• Patients must have a disease for which there is no known curative potential
• Patients must meet the following criteria for bone marrow function:
• Status post stem cell transplantation (SCT)
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3 (transfusion independent)
• Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)
• No lymphomas
• No CNS tumors or known metastatic disease to the brain or spinal cord
• Performance status - Karnofsky 50-100% (age 11 to 21)
• Performance status - Lansky 50-100% (age 1 to 10)
• At least 8 weeks
• See Disease Characteristics
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT no greater than 3 times ULN

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Cardiotoxicity

Interventions

oblimersen; Dexrazoxane; Razoxane; Doxorubicin; Cyclophosphamide; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Susan Rheingold

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: November 1, 2002
• Primary Completion: October 1, 2005
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)