NCT00316511

Brief Summary

This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be enrolled at that dose level. While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity, or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma patients will be assessed using the International Working Group recommendations.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

Enrollment Period

2.3 years

First QC Date

April 19, 2006

Last Update Submit

October 24, 2008

Conditions

MalignanciesB-Cell Lymphoma

Keywords

advanced solid malignanciesB-cell lymphomaAroplatinL-NDDPMTDadvanced solid malignancies or B-cell lymphoma

Outcome Measures

Primary Outcomes (3)

  • Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDP

  • Assess safety of L-NDDP

  • Determine the pharmacokinetic profile of L-NDDP

Secondary Outcomes (1)

  • Assess clinical activity

Interventions

AroplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid malignancies or B-cell lymphoma
  • Less than or equal to 5 anti-cancer treatment regimens, which must be concluded at least four weeks prior to the first planned L-NDDP administration
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • New York Heart Association (NYHA) Class I or II
  • Greater than or equal to 18 years of age
  • Absolute neutrophil count greater than or equal to 1.5 x 10\^9/L
  • Platelets greater than or equal to 100 x 10\^9/L
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
  • ALT less than 3 x ULN in absence of liver metastases; less than 5 x ULN in presence of liver metastases.
  • Hemoglobin greater than or equal to 10 g/dL
  • Total bilirubin less than or equal to 2 x ULN
  • Female of childbearing potential must have a negative serum pregnancy test
  • Male or female patients of child producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for one month after the last L-NDDP dose.
  • Signed written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and the rules followed at each institution.

You may not qualify if:

  • Known active or untreated brain metastases
  • Other ongoing systemic cancer therapies
  • Hypersensitivity to platinum compounds
  • Other active malignancies with the exception of adequately treated in-situ carcinoma of the uterine cervix, or non-melanoma skin cancer
  • A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration \[at least two assessments at a minimum of 48 hours apart\] of a QTc interval of \> 450 for males and \> 470 for females) or history of additional risk factors for torsades des pointes or use of concomitant medication prolonging the QT/QTc interval
  • Serious illness which, in the opinion of the Principal Investigator, would prevent study completion
  • Investigational therapy currently or within four weeks prior to planned first dose of L-NDDP
  • Women who are pregnant or breastfeeding will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

NeoplasmsLymphoma, B-Cell

Interventions

bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations

US(2)