Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

NCT00038142 | Terminated Phase 2 Results DMC

• 2 other identifiers: ID97-198NCI-2012-01285
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.
2. 2.To evaluate the feasibility and describe the toxicity associated with VACdxr.
3. 3.To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
4. 4.To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Conditions

Ewing's Sarcoma

Keywords

Ewing's Sarcoma; Vincristine; Doxorubicin; Adriamycin; Rubex; Cyclophosphamide; Dexrazoxane; Zinecard; VACdxr; ImmTher

Outcome Measures

Primary Outcomes (1)

• 2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer

  DFS defined as survival of participants to two years post study entry without relapse.

  2 years

Study Arms (2)

Arm A: VACdxr With ImmTher

EXPERIMENTAL

Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.

Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Dexrazoxane; Biological: ImmTher

Arm B: VACdxr

ACTIVE COMPARATOR

Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).

Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Dexrazoxane

Interventions

Vincristine DRUG

2.0 mg/m\^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.

Arm A: VACdxr With ImmTher; Arm B: VACdxr

Doxorubicin DRUG

90 mg/m\^2 IV over 30 min x 1 repeated every 3 weeks X 6.

Also known as: Adriamycin, Rubex

Arm A: VACdxr With ImmTher; Arm B: VACdxr

Cyclophosphamide DRUG

2.0 g/m\^2 IV daily x 2 days repeated every 3 weeks X 6.

Also known as: Cytoxan, Neosar

Arm A: VACdxr With ImmTher; Arm B: VACdxr

Dexrazoxane DRUG

900 mg/m\^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.

Also known as: DXR, Zinecard

Arm A: VACdxr With ImmTher; Arm B: VACdxr

ImmTher BIOLOGICAL

900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.

Arm A: VACdxr With ImmTher

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900 IU/ml prior to biopsy.
• No prior chemotherapy.
• Written informed consent
• Normal cardiac function (ejection fraction greater or equal to 50%).
• Males and non pregnant females.
• Biologic age 3-60 years old.
• Adequate bone marrow function (defined as an absolute peripheral granulocyte count of\>500/mm3, platelet count of \>75,000/mm3, and hemoglobin \>8g/dl with transfusion if required).
• Adequate renal function defined as blood urea nitrogen (BUN) \<30mg% and serum creatinine \<1.5 x normal for age or creatinine clearance \>70.
• Patients of child bearing potential must agree to use an effective method of contraception.
• Normal hepatic function (bilirubin \<1.5mg/dl, serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \<3x normal).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

Vincristine; Doxorubicin; Cyclophosphamide; Dexrazoxane; disaccharide tripeptide

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; 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; Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study terminated early leading to small numbers of subjects analyzed; therefore, unable to accrue required number of participants to determine statistical significance.

Results Point of Contact

• Title: Dr. Eugenie S. Kleinerman, Professor, Pediatrics - Research
• Organization: The University of Texas (UT) MD Anderson Cancer Center

ekleiner@mdanderson.org

713-792-8110

Study Officials

• Eugenie S. Kleinerman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2002
• First Posted: May 30, 2002
• Study Start: November 1, 1997
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Locations

US (1)