AFP464 in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery

NCT00348699 | Completed Phase 1

• 10 other identifiers: NCI-2009-00164MAYO-IAB-05-00404800MAYO-IAB-05-00404801NCI-7380CDR0000476275MAYO-MC0513MC05137380P30CA015083U01CA069912
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of AFP464 in treating patients with metastatic or refractory solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Recurrent Renal Cell Cancer; Stage IV Breast Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer; Stage IV Renal Cell Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (6)

• Maximum tolerated dose, overall toxicity incidence, and toxicity profiles of AFP464 in the treatment of solid tumors

  Measured by dose level and tumor site via the NCI CTCAE v 3.0. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

  28 days

• Overall response of AFP464 in the treatment of solid tumors

  Measured by Modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Summarized by simple descriptive summary statistics delineating complete and partial responses as well as table and progressive disease in the two patient populations (overall and by tumor group).

  Up to 3 months

• Time to progression

  Summarized descriptively.

  From registration to documentation of progression, assessed up to 3 months

• Time to treatment failure

  Summarized descriptively.

  From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months

• Urinary excretion of AFP464

  Examined with descriptive summary statistics and simple graphical tools. Computed and correlated with toxicity and response via Spearman correlation coefficients for continuous variables or Wilcoxon rank sum test if one binary variable is involved.

  Days 1-2, 8 and 15 of course 1

• Plasma area under the curve (AUC) of AFP464

  Examined with descriptive summary statistics and simple graphical tools. Computed and correlated with toxicity and response via Spearman correlation coefficients for continuous variables or Wilcoxon rank sum test if one binary variable is involved.

  Days 1-2, 8 and 15 of course 1

Secondary Outcomes (1)

• Percent change in CYP1A1

  Baseline to 24 hours post AFP-464

Study Arms (1)

Treatment (AFP464)

EXPERIMENTAL

Patients receive AFP464 IV over 3 hours on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: AFP464; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

AFP464 DRUG

Given IV

Treatment (AFP464)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (AFP464)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (AFP464)

Eligibility Criteria

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

You may qualify if:

• Histologic proof of cancer that is now unresectable
• Patients with metastatic solid tumors who are refractory to available therapy or for whom standard systemic therapy does not exist
• Absolute neutrophil count (ANC) \>= 1500/μL
• Platelets (PLT) \>= 100,000/μL
• Total bilirubin =\< upper limits of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
• Creatinine =\< 1.25 x ULN; if above 1.25 x ULN calculated creatinine clearance must be \>= 60 ml/min
• Hemoglobin (Hgb) \>= 9.0 g/dl
• Normal diffusing capacity of the lung for carbon monoxide (DLCO) or the presence of an asymptomatic grade 1 DLCO; NOTE: DLCO must be corrected for hemoglobin
• Ability to provide informed consent
• Willingness to return to Mayo Clinic for follow-up
• Life expectancy \>= 12 weeks
• Willingness to provide the biologic specimens (blood and urine) as required by the protocol
• COHORT II (MTD) PATIENTS ONLY:
• Patients with breast, ovarian, peritoneal or renal cell carcinoma

You may not qualify if:

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3 or 4
• Prior thoracic radiotherapy
• Symptomatic pulmonary disease
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements
• Any of the following prior therapies:
• Chemotherapy =\< 4 weeks prior to study entry
• Mitomycin C/nitrosoureas =\< 6 weeks prior to study entry
• Immunotherapy =\< 4 weeks prior to study entry
• Biologic therapy =\< 4 weeks prior to study entry
• Radiation therapy =\< 4 weeks prior to study entry
• Radiation to \> 25% of bone marrow
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Uncontrolled brain metastases; Note: Brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off steroids for \>= 4 weeks
• Any of the following:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Matthew Goetz

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2013
• Last Updated: February 24, 2014

Record last verified: 2011-12

Locations

US (1)