Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Newly Diagnosed Patients With Desmoplastic Small Round Cell Tumor

NCT01189643 | Active Not Recruiting Early Phase 1

• 1 other identifier: 10-091
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study adds irinotecan, temozolomide and bevacizumab to the chemotherapy regimen currently used to treat Desmoplastic small round cell tumor (DSRCT). The investigators are doing this study to find out what effects, good and/or bad, the combination of irinotecan, temozolomide and bevacizumab has on the patient and the DSRCT cancer.

Conditions

Sarcoma; Desmoplastic Small Round Cell Tumor (DSRCT)

Keywords

BEVACIZUMAB (AVASTIN); IRINOTECAN (CPT-11) CAMPTOSAR; TEMOZOLOMIDE; DSRCT; 10-091

Outcome Measures

Primary Outcomes (2)

• To define the tolerability

  of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT

  2 years

• To define adverse event profile

  of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT

  2 years

Secondary Outcomes (4)

• To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab

  2 years

• To estimate survival

  2 years

• To estimate time to progression

  2 years

• To assess use of 18FDG PET-CT

  2 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

This is a pilot study to evaluate the acute toxicities and activity of irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator based therapy in newly diagnosed patients with DSRCT.

Drug: irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator

Interventions

irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator DRUG

Two cycles of the investigational combination irinotecan, temozolomide and bevacizumab- will be given followed by conventional chemotherapy with a modified P6 approach and surgical local control. Completion of modified P6 chemotherapy will be followed by a second-look surgery.

Chemotherapy

Eligibility Criteria

• Age: 1 Year - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age greater than or equal to 1 year, less than 30 years
• Newly diagnosed, previously untreated patients with histologically or molecularly confirmed DSRCT
• Adequate hematologic function:
• Absolute neutrophil count ≥ 1,000/mm3
• Platelet count ≥ 100,000/mytm3
• Adequate renal function:
• Normal creatinine for age OR
• Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 x the ULN for age
• AST ≤ 2.5 x the ULN for age \[in the absence of hepatic involvement of tumor\]
• Normal cardiac function
• Shortening fraction greater than or equal to 28% by echocardiogram OR
• Left ventricular ejection fraction (LVEF) greater than or equal to 50% on technetium-99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram
• Hypertension must be well controlled on stable doses of medication for at least two weeks prior to enrollment.

You may not qualify if:

• Prior chemotherapy or radiotherapy
• Pregnant or breastfeeding females
• Patients with documented chronic non-healing wound, ulcer or bone fracture.
• Incomplete healing from previous oncologic or other major surgery.
• Surgical procedures:
• Patients who have undergone major surgery (including open biopsy, thoracotomy, organ resection, exploratory laparotomy, arteriovenous grafts) \<28 days prior to enrollment will have bevacizumab dosing delayed as outlined in section 9.1
• Patients must be at least 48 hours from placement of central catheter before receiving first dose of bevacizumab
• Minor surgical procedures (needle/laparoscopic core biopsies) for limited purposes of tissue retrieval will be allowed. Patients should not receive the first planned dose of bevacizumab until the wound is healed and 7 days have elapsed since the procedure.
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
• Thrombosis:
• Patients must not have had a deep venous or arterial thrombosis (non-central venous catheter related) within the last three months prior to study entry.
• Patients with cerebrovascular accident or transient ischemic attack within 6 months of therapy are excluded
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry.
• CNS status: Patients must not have known CNS metastases or leptomeningeal disease.
• Screening with brain imaging is not required for asymptomatic patients. Proteinuria: Urine protein: creatinine ratio greater than or equal to 1.0

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma; Desmoplastic Small Round Cell Tumor

Interventions

Irinotecan; Temozolomide; Alkylating Agents

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions

Study Officials

• Emily Slotkin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2010
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)