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Protocol RH-1-002: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Dose-escalation Study of RH-1 Administered as a 3-hour Intravenous Infusion in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Non-Hodgkin's Lymphoma

Thank you

Trial Information

Protocol RH-1-002: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Dose-escalation Study of RH-1 Administered as a 3-hour Intravenous Infusion in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma


Inclusion Criteria:



1. Histologically proven advanced solid tumors or NHL, relapsed or refractory to
conventional treatment, or for which no conventional therapy exists or is considered
acceptable for the patient.

2. Tumor accessible for biopsy (required in expanded cohort of 24 patients only;
optional in all other patients).

3. At least 18 years of age.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

5. Life expectancy ≥ 3 months.

6. Adequate hematological, hepatic, and renal function as defined by the following:
absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, total
bilirubin ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) ≤ 2.5 × ULN (AST/ALT ≤ 5 × ULN if documented
hepatic involvement), creatinine ≤ 1.5 mg/dL or if serum creatinine is elevated then
patient has a calculated creatinine clearance ≥ 50 mL/min.

7. Toxic manifestations of previous treatment(s) have resolved, with the exceptions of ≤
Grade 2 fatigue if stable for > 2 months, ≤ Grade 2 alopecia and/or other Grade 1
toxicities, which in the opinion of the investigator should not exclude the patient
(eg, palmar erythema; stable Grade 1 peripheral neuropathy).

8. Women of child-bearing potential must have a negative serum pregnancy test within 14
days prior to the first day of study treatment. Women who are postmenopausal for at
least 1 year (defined as > 12 months since last menses) or are surgically sterilized
do not require this test. Women of child-bearing potential and their male partners
must agree to practice a medically acceptable contraceptive regimen from study
treatment initiation until at least 30 days after the last administration of RH-1.
Adequate methods of contraception are double barrier methods (condoms with
spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam), oral, depot
and injectable contraceptives, and intrauterine device (IUD). RH-1 should not be
administered to women who are breast feeding.

9. Men who are not surgically sterile must agree to practice a medically acceptable
contraceptive regimen from study treatment initiation until at least 90 days after
the last administration of RH-1.

10. Given written informed consent (IC).

Exclusion Criteria:

1. Active concurrent malignancy, with the exception of adequately treated carcinoma in
situ of the cervix and/or basal or squamous cell carcinoma of the skin. If there is a
history of prior malignancy, the patient must be disease-free for ≥ 5 years.

2. Receipt of any investigational or conventional chemotherapy, targeted therapy,
endocrine therapy, or immunotherapy within 4 weeks prior to study treatment or
planned use during the course of the study. Hormonal therapy (gonadotropin-releasing
hormone analog [leuprolide] for prostate cancer, somatostatin analog [octreotide] for
carcinoid tumor, and anti-estrogens for breast cancer) will be allowed if the drug
administration has been stable for ≥ 4 weeks.

3. Use of any radiation therapy (RT) within 28 days prior to study treatment or planned
use during the course of the study.

4. Requires therapeutic levels of anticoagulation therapy.

5. Failed treatment with a bone marrow transplant.

6. Active uncontrolled infection, underlying medical condition such as patients at poor
medical risk because of non-malignant systemic disease, or other serious illness that
would impair the ability of the patient to receive protocol treatment.

7. Known to be positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus
(HIV).

8. Symptomatic central nervous system (CNS) metastases or lesions for which treatment is
required.

9. Major surgery within 4 weeks of planned start of treatment.

10. Previous exposure to RH-1.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of a 3-hour intravenous (IV) infusion of RH-1 administered once every 21 days.

Outcome Time Frame:

Study duration

Safety Issue:

Yes

Principal Investigator

D. Ross Camidge, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado Health Science Center

Authority:

United States: Food and Drug Administration

Study ID:

RH-1-002

NCT ID:

NCT00558727

Start Date:

November 2007

Completion Date:

December 2008

Related Keywords:

  • Advanced Solid Tumors
  • Non-Hodgkin's Lymphoma
  • Advanced Solid Tumors
  • Solid Tumors
  • Tumor
  • Non-Hodgkin's Lymphoma
  • Chemotherapy
  • Benzoquinone
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cancer Therapy & Research CenterSan Antonio, Texas  78229
University of Colorado Health Science CenterAurora, Colorado  80010-0510
Hudson-Webber Cancer Research CenterDetroit, Michigan  48201