Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzon Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.

• Target tumors outside prior radiation field(s).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.

• Adequate renal function

• Adequate liver function

• No history of hemorrhagic cystitis or evidence of microscopic hematuria

• Capable of understanding the protocol requirements and risks and providing written informed consent.

• Either 0 or 1 prior chemotherapy regimens

Exclusion Criteria:

• Subject has a diagnosis of gastrointestinal stromal tumors.

• Concurrent serious medical illness unrelated to tumor within the past 6 months.

• Known chronic infectious disease, such as AIDS or hepatitis.

• Positive screening pregnancy test or is breast-feeding.

• A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.

• Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.

• History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.

• Known or clinically suspected brain metastases.

• Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.

• Received any investigational drug within the last 30 days.

• Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.

• Received a prior camptothecin analog (e.g., topotecan, irinotecan).