Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00079950
Last Updated: 2012-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
PHASE2
INTERVENTIONAL
2003-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pegamotecan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Enzon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enzon Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Century City Hospital
Los Angeles, California, United States
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAM-9009
Identifier Type: -
Identifier Source: org_study_id