Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors

Recurrent Ovarian Germ Cell Tumor Clinical Trial

Official title:

Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01808534
• Other study ID #: IUCRO-0403
• Secondary ID: NCI-2013-0051013
• Status: Terminated
• Phase: Phase 2
• First received: March 6, 2013
• Last updated: June 11, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Description:

PRIMARY OBJECTIVES:

I. To determine the response rate (complete response [CR]+partial response [PR]) of single agent palifosfamide in patients with refractory germ cell tumors.

SECONDARY OBJECTIVES:

I. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors.

OUTLINE:

Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histological or serological proof of metastatic germ cell neoplasm (gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy; patients with seminoma and nonseminoma are eligible, as are women with ovarian germ cell tumors

• Patients must have evidence of recurrent or metastatic carcinoma by one or more of the criteria specified in the protocol

• Patients must have received initial cisplatin based combination therapy (such as bleomycin, etoposide and cisplatin [BEP], etoposide and cisplatin [EP], VP-16 plus ifosfamide plus cisplatin [VIP] or similar regimens) AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm (such as high dose chemotherapy, paclitaxel/ifosfamide/cisplatin [TIP] or vinblastine, ifosfamide and cisplatin [VeIP])

• Patients must have documented "failure" of prior therapy as defined in the protocol

• Patients are eligible after first line platinum based chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor (PMNSGCT) or late relapse (> 2 years) not amenable to surgical resection

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Laboratory test results must be within ranges established in the protocol

• Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information;

• Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use a highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug

Exclusion Criteria:

• No active clinically serious infections as judged by the treating investigator (> CTCAE grade 2) including known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or active hepatitis C

• No presence of, or history of any illness or injury to the urinary tract which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events

• Patients must not have any cardiac disorders as defined in the protocol

• No history of psychiatric illness/social situations that would limit compliance with study requirements

• Patients must be at least 4 weeks post major surgery or significant traumatic injury at time of study registration

• Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration

• Patients must not have a known sensitivity to any component of palifosfamide or its known excipients

• Patients with active central nervous system (CNS) metastases are excluded

• Patients must not have previously been exposed to palifosfamide

• Patients must have at least 3 weeks after previous radiotherapy or chemotherapy and have recovered from all major toxicities (except alopecia or grade 1 or 2 neuropathy) at the time of registration

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Central Nervous System Germ Cell Tumor
• Adult Teratoma
• Extragonadal Seminoma
• Germinoma
• Malignant Extragonadal Germ Cell Tumor
• Malignant Extragonadal Non-Seminomatous Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Neoplasms
• Recurrent Malignant Testicular Germ Cell Tumor
• Recurrent Ovarian Germ Cell Tumor
• Seminoma
• Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor
• Stage IV Extragonadal Seminoma
• Stage IV Ovarian Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• palifosfamide
Given IV

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (Defined as Partial Response or Complete Response)	The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.	Up to 2 years	No
Secondary	Duration of Remission in Patients Who Achieve a Partial or Complete Response	The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.	Up to 2 years	No
Secondary	Progression Free Survival (PFS)	Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.	Up to 2 years	No
Secondary	Overall Survival	Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.	Up to 2 years	No
Secondary	Treatment Related Adverse Events Grade 3 or Higher	Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.	Up to 2 years	Yes