Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors

NCT01808534 | Terminated Phase 2 Results

• 3 other identifiers: IUCRO-0403NCI-2013-005101301010501
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Adult Central Nervous System Germ Cell Tumor; Adult Teratoma; Malignant Extragonadal Germ Cell Tumor; Malignant Extragonadal Non-Seminomatous Germ Cell Tumor; Extragonadal Seminoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Ovarian Germ Cell Tumor; Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor; Stage IV Extragonadal Seminoma; Stage IV Ovarian Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Duration of Remission in Patients Who Achieve a Partial or Complete Response

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall Survival

  Up to 2 years

• Treatment Related Adverse Events Grade 3 or Higher

  Up to 2 years

Study Arms (1)

Treatment (palifosfamide)

EXPERIMENTAL

Patients receive palifosfamide 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.

Drug: palifosfamide

Interventions

palifosfamide DRUG

Given IV

Also known as: IPM-lysine, isophosphoramide mustard-lysine, ZIO-201

Treatment (palifosfamide)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Alaunos Therapeutics: collaborator

Study Sites (3)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Teratoma; Testicular Neoplasms

Interventions

isophosphamide mustard; Ifosfamide; palifosfamide lysine

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Lawrence H. Einhorn
• Organization: IndianaU

leinhorn@iu.edu

(317)274-3515

Study Officials

• Lawrence H Einhorn, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 2, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

US (3)