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Advanced Solid TumorsPhase 1NCT00558727

Study of RH-1 in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

A Phase 1 study testing RH-1 in people with Advanced Solid Tumors and Non-Hodgkin's Lymphoma, run by Spectrum Pharmaceuticals, Inc at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL). Treatment will continue until a patient meets criteria for discontinuation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Non-Hodgkin's Lymphoma
What is being tested?
RH-1
Type of treatment
Injection or infusion
How many people
12 participants
Where
4 sitesUnited States
Study dates
Nov 2007to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Tumor accessible for biopsy (required in expanded cohort of 24 patients only; optional in all other patients).
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy ≥ 3 months.
  • 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.
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  • 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).
  • 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.
  • 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.
  • Given written informed consent (IC).

Who cannot join

  • 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.
  • 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.
  • Use of any radiation therapy (RT) within 28 days prior to study treatment or planned use during the course of the study.
  • Requires therapeutic levels of anticoagulation therapy.
  • Failed treatment with a bone marrow transplant.
  • 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.
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  • Known to be positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
  • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required.
  • Major surgery within 4 weeks of planned start of treatment.
  • Previous exposure to RH-1.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado Health Science Center

    Aurora, Colorado, 80010

  • Hudson-Webber Cancer Research Center

    Detroit, Michigan, 48201

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Cancer Therapy & Research Center

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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

This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).

Treatment will continue until a patient meets criteria for discontinuation.

Being tested
RH-1
Keywords
Advanced Solid Tumors, Solid Tumors, Tumor, Non-Hodgkin's Lymphoma, Chemotherapy, Benzoquinone
Medical subject headings
Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RH-1Drug

    Also called 2,5-diaziridinyl-3-[hydroxymethyl]-6-methyl-1,4-benzoquinone

    1.5 mg/m2 to 12 mg/m2, depending on protocol cohort, administered via intravenous (IV) infusion over 3 hours once every 21 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Study duration

Secondary outcomes (5)

  1. To evaluate the safety and tolerability of 3-hour IV infusions of RH-1.

    Measured: Study duration

  2. To determine the pharmacokinetic (PK) profile of 3-hour IV infusions of RH-1 administered at escalating doses.

    Measured: Study duration

  3. To assess preliminary evidence of anti-cancer activity of RH-1.

    Measured: Study duration

  4. To explore evidence of differential deoxyribonucleic acid (DNA) cross-linking and downstream phenotypic consequences of RH-1 exposure in peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), and tumor biopsies.

    Measured: Study duration

  5. To explore the correlation and possible significance of germline polymorphisms in NAD(P)H:quinone oxidoreductase (NQO1) and DNA cross-linking as consequences of RH-1 exposure in PBMCs, CTCs, and tumor biopsies, as markers of anticancer activity.

    Measured: Study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558727
Sponsor's protocol ID
RH-1-002
Status last verified
May 2013
First submitted
13 Nov 2007
Last updated
10 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RH-1 in people with Advanced Solid Tumors and Non-Hodgkin's Lymphoma, run by Spectrum Pharmaceuticals, Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. (time frame: Study duration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.

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