Neoplasms

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Irinotecan

Doxorubicin

Liposomal doxorubicin

Temozolomide

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Tubulin Modulators

Antimitotic Agents

Regimen A alternating with Regimen B every 21 days

Regimen A:

* Cytoxan 1200mg/m2
* Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2
* Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg
* Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle

Regimen B:

* Irinotecan 50 mg/m2/day x 5 days
* Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free

100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Starting dose 75 mg/m2 to a maximum of 450mg/m2

Cytoxan

6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Pegfilgrastim

Kristen N. Ganjoo

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma

Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.

Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.

The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.

Amgen

Stanford University

Assistant Professor of Medicine

Patients were asked about adverse events at every clinic visit.

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS

Combination Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study did not reach primary objective; study didn't accrue enough patients.

Kristen Ganjoo, MD

Overall Response Rate (Partial and Complete Response)

All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data.

Progression-free Survival (PFS)

Overall Study

Spots Global Cancer Trial Database for Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial