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Trial record 8 of 203 for:    ewing sarcoma

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038142
First received: May 29, 2002
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

Objectives:

  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. To evaluate the feasibility and describe the toxicity associated with VACdxr.
  3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
  4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Condition Intervention Phase
Ewing's Sarcoma
Drug: Vincristine
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Dexrazoxane
Biological: ImmTher
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To see if treatment with the drugs, vincristine, doxorubicin, cyclophosphamide and dexrazoxane (VACdxr) given in high doses with or without ImmTher will help patients with Ewing's Sarcoma live longer. [ Time Frame: 13 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 104
Study Start Date: November 1997
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: VACdxr With ImmTher
Vincristine 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. Doxorubicin 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. Cyclophosphamide 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. Dexrazoxane 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6. ImmTher 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
Drug: Vincristine
2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
Drug: Doxorubicin
90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.
Other Names:
  • Adriamycin
  • Rubex
Drug: Cyclophosphamide
2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.
Other Names:
  • Cytoxan
  • Neosar
Drug: Dexrazoxane
900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
Other Names:
  • DXR
  • Zinecard
Biological: ImmTher
900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
Active Comparator: Arm B: VACdxr
Vincristine 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. Doxorubicin 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. Cyclophosphamide 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. Dexrazoxane 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
Drug: Vincristine
2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
Drug: Doxorubicin
90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.
Other Names:
  • Adriamycin
  • Rubex
Drug: Cyclophosphamide
2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.
Other Names:
  • Cytoxan
  • Neosar
Drug: Dexrazoxane
900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
Other Names:
  • DXR
  • Zinecard

Detailed Description:

Patients will be assigned at random (as by the toss of a coin) to receive 1 of 2 treatments.

Arm A: VACdxr will be given over 2 days through a needle in a vein. On day 1, vincristine will be given over 15 minutes, and doxorubicin will be given over 30 minutes.

Dexrazoxane will be given 30 minutes before doxorubicin; this drug protects the heart from damage by doxorubicin. Cyclophosphamide will be given once a day on days 1 and 2. This will make up 1 cycle of VACdxr treatment; the cycle will be repeated every 3 weeks for up to 6 cycles.

To prevent some side effects of VACdxr, the drugs Mesna and Neupogen/or Neulasta will also be given. Mesna helps prevent bladder damage. Neupogen is a growth factor that stimulates the body to make more white blood cells. Neulasta is a growth factor related to Neupogen.

After cycle 3, surgery may be done to remove any tumor that remains. The principal investigator will also decide whether radiation treatment should be done. If so, patients will receive radiation therapy.

Starting 1 month after all treatment is done, patients will receive ImmTher. ImmTher stimulates the body's white blood cells to attack and kill tumor cells. The drug will be given through a needle in a vein over 1 hour, every week for 1 year.

Arm B: Patients will be treated the same as patients in Arm A, except that they will not receive ImmTher.

Patients may have to stay in the hospital during VACdxr treatment and after surgery. Patients will receive ImmTher in the outpatient clinic.

Before treatment starts, patients will have a complete exam including blood and urine tests and an EKG and ECHO or MUGA (heart function tests). X-rays and CT, MRI, bone marrow aspiration, and bone scans will be done. Women will have a pregnancy test.

After each treatment with drugs, after surgery, and after radiation treatment, patients will have checkups. These will include blood and urine tests and sometimes x-rays.

After cycle 3 of VACdxr, patients will have chest x-ray and x-ray of primary tumor. CT chest, MRI, bone marrow aspiration and bone scans will be done after 3 cycles as indicated. These tests will be done to record and measure tumors.

After treatment stops, patients will return for checkups every 3 months for 2 years.

This is an investigational study. ImmTher is an investigational agent. All other study drugs are approved by the U.S. Food and Drug Administration. As many as 104 patients will take part in the study; about 95 of these will be treated at M.D. Anderson.

  Eligibility

Ages Eligible for Study:   3 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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, SGOT or SGPT <3x normal).

Exclusion Criteria: N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038142

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eugenie S. Kleinerman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038142     History of Changes
Other Study ID Numbers: ID97-198, NCI-2012-01285
Study First Received: May 29, 2002
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Ewing's Sarcoma
Vincristine
Doxorubicin
Adriamycin
Rubex
Cyclophosphamide
Dexrazoxane
Zinecard
VACdxr
ImmTher

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Osteosarcoma
Cyclophosphamide
Dexrazoxane
Doxorubicin
Liposomal doxorubicin
Razoxane
Vincristine
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014