Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

NCT00064220 | Completed Phase 2

• 4 other identifiers: CDR0000310138DAIICHI-1027A-PRT007CPMC-IRB-20030512MSKCC-03061
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 6

Brief Summary

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.

Conditions

Sarcoma

Keywords

adult leiomyosarcoma; adult malignant fibrous histiocytoma; adult liposarcoma; adult rhabdomyosarcoma; adult synovial sarcoma; adult fibrosarcoma; adult angiosarcoma; adult malignant hemangiopericytoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma

Interventions

soblidotin DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma of 1 of the following tumor types: * Malignant fibrous histiocytoma * Liposarcoma * Rhabdomyosarcoma * Synovial sarcoma * Malignant paraganglioma * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma, including hemangiopericytoma * Malignant peripheral nerve sheath tumor * Unclassified sarcoma * Miscellaneous sarcoma, including mixed mesodermal tumors of the uterus * The following tumor types are not eligible: * Gastrointestinal stromal tumor * Chondrosarcoma * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Ewing's sarcoma * Embryonal rhabdomyosarcoma * Evidence of disease progression * Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease * Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy * At least 1 measurable lesion with indicator lesions outside of any prior radiation field * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 15 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin no greater than 1.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * Ejection fraction at least 40% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No baseline neurotoxicity grade 2 or greater * No concurrent serious infection * No psychiatric disorder that would preclude giving informed consent or complying with study requirements * No other concurrent severe or uncontrolled medical illness that would preclude study participation * No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No concurrent radiotherapy * Localized radiotherapy to a non-indicator lesion for pain relief allowed provided all other methods of pain control are ineffective Surgery * At least 4 weeks since prior major surgery and recovered Other * At least 4 weeks since prior myelosuppressive therapy * At least 4 weeks since prior investigational drugs * No other concurrent investigational drugs * No other concurrent anticancer cytotoxic therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related Publications (1)

• Patel S, Keohan ML, Saif MW, Rushing D, Baez L, Feit K, DeJager R, Anderson S. Phase II study of intravenous TZT-1027 in patients with advanced or metastatic soft-tissue sarcomas with prior exposure to anthracycline-based chemotherapy. Cancer. 2006 Dec 15;107(12):2881-7. doi: 10.1002/cncr.22334.

  PMID: 17109446 RESULT

MeSH Terms

Conditions

Sarcoma; Leiomyosarcoma; Histiocytoma, Malignant Fibrous; Liposarcoma; Rhabdomyosarcoma; Sarcoma, Synovial; Fibrosarcoma; Hemangiosarcoma; Hemangiopericytoma, Malignant

Interventions

soblidotin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Myosarcoma; Neoplasms, Vascular Tissue

Study Officials

• Juan Pagan

  Daiichi Sankyo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: April 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

PR (1); US (5)