Determining a maximum tolerated cumulative dose: Dose reassignment within the TITE-CRM

Controlled Clinical Trials

Volumn 24, Issue 6, 2003, Pages 669-681

  Braun, Thomas M ^a   Levine, John E ^b   Ferrara, James L M ^b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

Author keywords

Bayesian inference; Bone marrow transplant; Phase I trial

Indexed keywords

RECOMBINANT KERATINOCYTE GROWTH FACTOR;

ARTICLE; BONE MARROW TRANSPLANTATION; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG MEGADOSE; GRAFT VERSUS HOST REACTION; HUMAN; LOW DRUG DOSE; MATHEMATICAL ANALYSIS; MAXIMUM TOLERATED DOSE; METHODOLOGY; OPTIMAL DRUG DOSE; PHASE 1 CLINICAL TRIAL; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; STATISTICAL MODEL; TOXICITY;

EID: 0345549608     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(03)00094-1     Document Type: Article

References (12)

1. Farrell C.L., Bready J.V., Rex K.L., et al. Keratinocyte growth factor protects mice from chemotherapy and radiation-induced gastrointestinal injury and mortality. Cancer Res. 58:1998;933-939.
2. Krijanovski O.I., Hill G.R., Cooke K.R., et al. Keratinocyte growth factor separates graft-versus-leukemia effects from graft-versus-host disease. Blood. 94:1999;825-831.
3. Hill G.R., Ferrara J.L.M. The primacy of the gastrointestinal tract as a target organ of acute graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow transplantation. Blood. 95:2000;2754-2759.
4. O'Quigley J., Pepe M., Fisher L. A practical design for phase I clinical trials in cancer. Biometrics. 46:1990;33-48.
5. Goodman S., Zahurak M., Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 14:1995;1149-1161.
6. Babb J., Rogatko A., Zacks S. Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat Med. 17:1998;1103-1120.
7. Gasparini M., Eisele J. A curve-free method for phase I clinical trials. Biometrics. 56:2000;609-615.
8. Leung D.H.-Y., Wang Y.-G. Isotonic designs for phase I trials. Control Clin Trials. 22:2001;126-138.
9. Cheung Y.K., Chappell R.J. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics. 56:2000;1177-1182.
10. McCullagh P., Nelder J.A. Generalized linear models. 2nd ed. 1989;Chapman & Hall, London.
11. Shen L.Z., O'Quigley J. Consistency of continual reassessment method under model misspecification. Biometrics. 83:1996;395-405.
12. O'Quigley J., Shen L.Z. Continual reassessment method: a likelihood approach. Biometrics. 52:1996;673-684.