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Completed

NCT Number: NCT00530192

Molecular Profiling Protocol (SCRI-CA-001)

This is an open-label, multicenter pilot study in patients with advanced solid tumors.

The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

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Key information

Conditions

Refractory Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Oncology Specialties, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
  • Be defined as refractory to the last line of therapy
  • Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

Exclusion criteria

  • Patients with symptomatic CNS metastasis
  • Any previous history of another malignancy within 5 years of study entry
  • Uncontrolled intercurrent illness
  • Known HIV, HBV, HCV infection
  • Pregnant or breast-feeding

Treatment and study plan

Treatment based on Molecular Profiling

Other

Treatment with commercially available treatments (per package insert instructions)

Primary outcomes

  1. To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

    Time frame: Every 8 weeks disease assessments are performed

Secondary outcomes

  1. To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.

    Time frame: Time of Profiling- Baseline

  2. To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Scottsdale Healthcare

Other

Collaborators

  • Translational Genomics Research Institute

Registry information

Official study title

A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 17, 2007
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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