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

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AFP464 in Treating Patients With Advanced Solid Tumors

NCT00369200

Unspecified Adult Solid Tumor, Protocol Specific

TERMINATED PHASE1

Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors

NCT00003768

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors

NCT00113438

Cancer Tumor

COMPLETED PHASE2

Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

NCT00387504

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

NCT00008086

Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of AFP464 in patients with advanced solid tumors.

II. Evaluate the toxicity profile of AFP464. III. Characterize the plasma pharmacokinetics and urinary excretion of AFP464 and aminoflavone in these patients.

IV. Identify any activity of AFP464 in patients with metastatic cancer. V. Explore whether AFP464 induces cytochrome p450, family 1, member A1 (CYP1A1) expression in tumor (patients enrolled at the MTD) (patients enrolled at the MTD) and/or circulating tumor cells (CTCs) (dose-escalation phase and at the MTD).

VI. To explore the relationship between the pharmacogenetic analysis and toxicity or response.

OUTLINE: This is a dose-escalation study.

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

After completion of study treatment, patients are followed up for up to 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (AFP464)

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.

Group Type EXPERIMENTAL

AFP464

Intervention Type DRUG

Given IV

pharmacological study

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AFP464

Given IV

Intervention Type DRUG

pharmacological study

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

pharmacological studies

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* Tumor that is amenable for biopsy taken during Cycle 1 at 24 +/- 4 hours following the end of AFP-464 infusion
* International normalized ratio (INR) =\< 1.4
* Patients taking aspirin: discontinue \>= 5 days prior to procedure
* Patients receiving IV Heparin: discontinue 4 hours prior to the procedure and an APTT measurement obtained if clinically indicated
* Patients receiving subcutaneous or low molecular weight heparin: discontinue for 8 hours prior to procedure

Exclusion Criteria

* 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:

* Pregnant women: Females of childbearing potential must have a negative serum pregnancy test =\< 7 days prior to registration
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.)
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to AFP464
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
* Active smokers and those who have smoked =\< 30 days prior to registration, and patients unwilling or unable to refrain completely from smoking while on study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No