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A Phase I Dose-Escalation Trial of Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Refractory or Relapsed Solid Tumors

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Trial Information

A Phase I Dose-Escalation Trial of Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors


Inclusion Criteria:



- Able to provide informed consent

- Not on immune-modulating drugs, except those used as study drug premedication, unless
the principal investigator grants an exception (which exception must be documented in
writing)

- Patients with relapsed or refractory solid tumors with no viable treatment options

- Measurable disease within 30 days of study enrollment

- Blood hemoglobin > 8.5 gm/dl within 7 days of study enrollment

- Absolute neutrophil count > 1000/mm3 within 7 days of study enrollment

- Platelet count > 50,000/mm3 within 7 days of study enrollment

- SGOT <10x upper limit of normal within 7 days of study enrollment

- No chemotherapy or radiation therapy in the 14 days prior to initiation of treatment
on this study. No other concurrent chemotherapy, surgery or radiation therapy during
this protocol except surgery or radiation therapy to control symptoms with
concurrence of the principal investigator.

- No contraindication to any study treatment

- No active major medical problems, including untreated or uncontrolled infections

- If of reproductive potential, a negative urine or blood pregnancy test within 3 days
of study enrollment, and agreement to use adequate contraception. In relevant
subjects, pregnancy testing will continue monthly while on treatment unless the
subject is no longer able to become pregnant or there is sufficient justification
otherwise

- Not breast feeding

- Life expectancy > 6 months

- ECOG performance status < 2

- Age 18+ years

- No active substance abuse in the prior 6 months

- Not on digoxin or cimetidine

Exclusion Criteria:

- Contraindication or hypersensitivity to any study drug or its components or
excipients

- Current pregnancy or breast feeding

- Inability to document adequate contraception if a female of reproductive potential

- Chemotherapy or radiation therapy within the 14 days prior to initiation of study
treatment

- Prior treatment with sorafenib. Prior HCQ use is not an exclusion.

- Life expectancy < 6 months

- ECOG performance status > 2

- Symptomatic coronary artery disease (including uncontrolled angina, congestive heart
failure, and the like)

- Uncontrolled hypertension (diastolic BP consistently >100 mm Hg or systolic BP
consistently >160 mm Hg on a regular basis)

- Uncontrolled, symptomatic cardiac arrhythmia

- Active substance abuse in the prior 6 months

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Description:

To assess the toxicities of combining sorafenib plus HCQ in this patient population

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Tyler Curiel, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Health Science Center San Antonio

Authority:

United States: Institutional Review Board

Study ID:

CTRC 11-71

NCT ID:

NCT01634893

Start Date:

June 2012

Completion Date:

July 2022

Related Keywords:

  • Refractory or Relapsed Solid Tumors
  • Refractory or Relapsed Solid Tumors
  • Neoplasms

Name

Location

Cancer Therapy and Research Center at UTHSCSASan Antonio, Texas  78229