Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma

Completed · Phase 1/Phase 2

Conditions studied: Soft Tissue Sarcoma

In brief

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.

Key facts

Study ID

NCT00742963

Run by

ImmunoGenesis

People needed

107

Starts

2008-08-01

Expected to finish

2013-10-01

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Subjects:
• At least 18 years of age
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
• Pathologically confirmed diagnosis of soft tissue sarcoma of the following subtypes:
• Synovial sarcoma
• High grade fibrosarcoma
• Unclassified, undifferentiated sarcoma
• Liposarcoma
• Leiomyosarcoma (excluding GIST)
• Angiosarcoma (excluding Kaposi's sarcoma)
• Pleomorphic sarcoma/malignant fibrous histiocytoma
• Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate; subjects in the dose escalation cohorts must have progressed since their most recent systemic therapy
• Recovered from reversible toxicities of prior therapy
• Evaluable disease by RECIST criteria (at least one target or non-target lesion for dose escalation cohorts; at least 1 target lesion for dose expansion cohort)
• ECOG performance status of 0 or 1
• Life expectancy of at least 3 months
• Acceptable liver function:
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
• Acceptable renal function:
• Serum creatinine within normal limits
• Acceptable hematologic status (without hematologic support):
• ANC ≥ 1500 cells/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9.0 g/dL

You may not qualify if…

• Prior therapy:
• Dose escalation cohort: Prior treatment with more than 2 myelosuppressive cytotoxic chemotherapy regimens
• Expanded cohort: Prior systemic therapy for advanced disease (neoadjuvant and adjuvant permitted)
• Low grade tumors according to standard grading systems (eg AJCC Grade 1 and 2)
• Prior therapy with ifosfamide or cyclophosphamide
• Prior therapy with an anthracycline or anthracenedione
• Prior mediastinal/cardiac radiotherapy
• Current use of drugs with known cardiotoxicity or known interactions with doxorubicin (see product label)
• Anticancer treatment with radiation therapy, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
• Significant cardiac dysfunction:
• Any history of congestive heart failure
• Any history of transmural myocardial infarction
• Uncontrolled arrhythmias within the past 6 months
• Angina pectoris requiring antianginal medication within the past 6 months
• Clinically significant valvular heart disease
• Poorly controlled hypertension within the last 6 months
• Seizure disorders requiring anticonvulsant therapy
• Known brain metastases (unless previously treated and well controlled for a period of ≥ 3 months) Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
• Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Prior therapy with an hypoxic cytotoxin
• Subjects who participated in an investigational drug or device study within 28 days prior to study entry
• Known infection with HIV, hepatitis B, or hepatitis C
• Subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to TH-302

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washingon University Siteman Cancer Center — St Louis, Missouri, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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