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A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors


I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients
with metastatic or unresectable solid tumors.

II. Determine the safety and dose-limiting toxic effects of this drug in these patients.

III. Determine, preliminarily, the efficacy of this drug in these patients.


I. Determine the pharmacokinetic parameters of this drug and its metabolites in these

II. Correlate pharmacokinetic parameters with clinical effects of this drug in these

OUTLINE: This is an open-label, dose-escalation study.

Patients receive SJG-136 IV over 20 minutes once daily on days 1-3. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

After completion of study treatment, patients are followed for 30 days.

Inclusion Criteria:

- Patients must have histologically confirmed solid tumor malignancy that is metastatic
or unresectable and for which standard curative or palliative measures do not exist
or are no longer effective

- Prior chemotherapy or immunotherapy allowed

- Time interval must be at least 4 weeks since prior chemotherapy or immunotherapy, 6
weeks if the last regimen included BCNU or mitomycin C

- Radiation therapy to < 25% of hematopoietic bone marrow is allowed

- ECOG performance status =<2 (Karnofsky => 60%)

- Life expectancy of greater than three months

- Recovered from prior therapy

- 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

- Ability to understand and the willingness to sign a written informed consent document

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

- No unstable angina pectoris

Exclusion Criteria:

- Patients receiving any other investigational agents

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study

- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with SJG-136, breastfeeding should be
discontinued if the mother is treated with SJG-136

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to SJG-136

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with SJG-136

- With the exception of alopecia (and other situations in which the organ dysfunction
or symptoms are considered clinically insignificant or irrelevant to this study),
patients may not have baseline organ dysfunction or symptoms that qualify as Grade 2
or greater by CTC AE v. 3.0

- No other chemotherapy, immunotherapy, radiation therapy, surgery for cancer
(including resection of any metastases), specific antitimor therapy, or experimental
medications will be permitted while the patients are participating in this study

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Palliative radiation therapy is not allowed

Type of Study:


Study Design:

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

Outcome Measure:

MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Igor Puzanov

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



Vanderbilt University Nashville, Tennessee  37232-6305